Pseudoephedrine/

Chlorpheniramine/

Dextromethorphan Oral Suspension

Generic Name: Pseudoephedrine/Chlorpheniramine/Dextromethorphan (SOO-doe-e-FED-rin/KLOR-fen-IR-a-meen/DEX-troe-meth-OR-fan)
Brand Name: Generic only. No brands available.

Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension if:

• you are allergic to any ingredient in Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, stomach ulcer, or narrow-angle glaucoma
• you are unable to urinate or are having an asthma attack
• you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
• you are pregnant or breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension:

Some medical conditions may interact with Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; sleep apnea; mental or mood problems (eg, depression); or an overactive thyroid
• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus
• if you have a history of alcohol abuse, are in poor heath, are very overweight, or are confined to a bed

Some MEDICINES MAY INTERACT with Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension’s side effects
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension:

Use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension with a full glass of water (8 oz/240 mL).
• If you miss a dose of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension.

Important safety information:

• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do not take diet or appetite control medicines while you take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension without checking with your doctor.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension has pseudoephedrine, chlorpheniramine, and dextromethorphan in it. Before you start any new medicine, check the label to see if it has pseudoephedrine, chlorpheniramine, or dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.
• Contact your doctor if you have a sore throat that is severe, lasts more than 2 days, or occurs with fever, rash, headache, nausea, or vomiting.
• Tell your doctor if you have a fever that lasts more than 3 days or becomes worse.
• Contact your doctor if you have a cough that lasts more than 7 days or occurs with fever, rash, or persistent headache.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension for a few days before the tests.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension.
• Tell your doctor or dentist that you take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension before you receive any medical or dental care, emergency care, or surgery.
• Use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.
• Caution is advised when using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension should not be used in CHILDREN younger than 6 years old without first checking with the child’s doctor; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension while you are pregnant. Some ingredients of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension are found in breast milk. Do not breast-feed while taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension.

When used for long periods of time or at high doses, Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension stops working well. Do not take more than prescribed.

Some people who use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension suddenly, you may have WITHDRAWAL symptoms. These may include mental or mood changes (eg, depression).

Possible side effects of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; increased sweating; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest tightness; clumsiness or unsteadiness; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; flushing or redness of the face; hallucinations; mental or mood changes; numbness or tingling; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; vision problems (eg, double vision, severe or persistent blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusual eye movements; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension:

Store Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Chlorpheniramine/Dextromethorphan Oral Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pseudoephedrine/

Chlorpheniramine/

Dextromethorphan Drops Drops

Generic Name: Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops (SOO-doe-e-FED-rin/KLOR-fen-IR-a-meen/DEX-troe-meth-OR-fan)
Brand Name: Examples include Neutrahist PDX and AccuHist PDX

Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops are used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops are a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops if:

• you are allergic to any ingredient in Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, stomach ulcer, or narrow-angle glaucoma
• you are unable to urinate or are having an asthma attack
• you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
• you are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops:

Some medical conditions may interact with Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, stroke, glaucoma or increased pressure in the eye, or thyroid problems
• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus
• if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; trouble urinating; or an enlarged prostate or other prostate problems
• if you are in poor health
• if you take medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), furazolidone, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops’s side effects
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops:

Use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Use the dropper that comes with Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops.

Important safety information:

• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do not take diet or appetite control medicines while you take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops without checking with your doctor.
• Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, or smoking). However, you may use it for these conditions if your doctor tells you to.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 to 7 days, if they get worse, or if they occur along with a fever, check with your doctor.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops for a few days before the tests.
• Tell your doctor or dentist that you take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops before you receive any medical or dental care, emergency care, or surgery.
• Use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.
• Caution is advised when using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops in CHILDREN; they may be more sensitive to its effects, especially excitability.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops while you are pregnant. Some ingredients of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops are found in breast milk. Do not breast-feed while taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops.

Possible side effects of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; flushing; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops:

Store Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Chlorpheniramine/Dextromethorphan Drops Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pseudoephedrine/

Chlorpheniramine/

Dextromethorphan Tablets

Generic Name: Pseudoephedrine/Chlorpheniramine/Dextromethorphan (SOO-doe-e-FED-rin/KLOR-fen-IR-a-meen/DEX-troe-meth-OR-fan)
Brand Name: Maxichlor PSE DM

Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets if:

• you are allergic to any ingredient in Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, stomach ulcer, or narrow-angle glaucoma
• you are unable to urinate or are having an asthma attack
• you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets:

Some medical conditions may interact with Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; sleep apnea; mental or mood problems (eg, depression); or an overactive thyroid
• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus
• if you have a history of alcohol abuse, are in poor heath, are very overweight, or are confined to a bed

Some MEDICINES MAY INTERACT with Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets’s side effects
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets:

Use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets with a full glass of water (8 oz/240 mL).
• If you miss a dose of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets.

Important safety information:

• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do not take diet or appetite control medicines while you take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets without checking with your doctor.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets has pseudoephedrine, chlorpheniramine, and dextromethorphan in it. Before you start any new medicine, check the label to see if it has pseudoephedrine, chlorpheniramine, or dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.
• Contact your doctor if you have a sore throat that is severe, lasts more than 2 days, or occurs with fever, rash, headache, nausea, or vomiting.
• Tell your doctor if you have a fever that lasts more than 3 days or becomes worse.
• Contact your doctor if you have a cough that lasts more than 7 days or occurs with fever, rash, or persistent headache.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets for a few days before the tests.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets.
• Tell your doctor or dentist that you take Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets before you receive any medical or dental care, emergency care, or surgery.
• Use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.
• Caution is advised when using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets in CHILDREN; they may be more sensitive to its effects, especially excitability.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets should not be used in CHILDREN younger than 6 years old without first checking with the child’s doctor; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets while you are pregnant. It is not known if Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets is found in breast milk. Do not breast-feed while taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets.

When used for long periods of time or at high doses, Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets stops working well. Do not take more than prescribed.

Some people who use Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets suddenly, you may have WITHDRAWAL symptoms. These may include mental or mood changes (eg, depression).

Possible side effects of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; increased sweating; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest tightness; clumsiness or unsteadiness; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or sore throat; flushing or redness of the face; hallucinations; mental or mood changes; numbness or tingling; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; vision problems (eg, double vision, severe or persistent blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusual eye movements; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets:

Store Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Chlorpheniramine/Dextromethorphan Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pseudoephedrine/

Codeine Liquid

Generic Name: Pseudoephedrine/Codeine (SOO-doe-e-FED-rin/KOE-deen)
Brand Name: Examples include Notuss-DC and Nucofed

Pseudoephedrine/Codeine Liquid is used for:

Relieving nasal congestion and cough due to colds, flu, or allergies. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Codeine Liquid is a decongestant and narcotic cough suppressant. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Pseudoephedrine/Codeine Liquid if:

• you are allergic to any ingredient in Pseudoephedrine/Codeine Liquid or any other codeine or morphine related medicine (eg, oxycodone)
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Codeine Liquid:

Some medical conditions may interact with Pseudoephedrine/Codeine Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, dihydrocodeine, hydrocodone, oxycodone)
• if you have a history of glaucoma or increased pressure in the eye, prostate problems (eg, enlarged prostate gland), heart problems, diabetes, high blood pressure, blood vessel problems, stroke, adrenal gland problems, liver problems, or thyroid problems, or if you have trouble urinating
• if you have a history of stomach or bowel problems (eg, constipation, inflammation, ulcer), severe diarrhea caused by antibiotic use, or gallbladder problems (eg, gallstones), or if you have had recent stomach or bowel surgery
• if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema, shortness of breath), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus
• if you are dehydrated, very overweight, or have a condition that causes severe drowsiness
• if you have a head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures, or if you have recently had any of these conditions
• if you have a history of alcohol or substance abuse, mental or mood problems, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Pseudoephedrine/Codeine Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin, droxidopa, or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, irregular heartbeat, or heart attack may be increased
• Beta-blockers (eg, propranolol), cimetidine, COMT inhibitors (eg, tolcapone), furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk Pseudoephedrine/Codeine Liquid’s side effects
• Naltrexone, quinidine, or rifampin because they may decrease Pseudoephedrine/Codeine Liquid’s effectiveness
• Bromocriptine because the risk of its side effects may be increased by Pseudoephedrine/Codeine Liquid
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Codeine Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Codeine Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Codeine Liquid:

Use Pseudoephedrine/Codeine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine/Codeine Liquid by mouth with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you have trouble sleeping from Pseudoephedrine/Codeine Liquid, try not to take it within a few hours before bedtime. This may help to decrease sleeplessness caused by Pseudoephedrine/Codeine Liquid.
• If you miss a dose of Pseudoephedrine/Codeine Liquid and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Codeine Liquid.

Important safety information:

• Pseudoephedrine/Codeine Liquid may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Codeine Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Codeine Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Codeine Liquid without checking with your doctor.
• Pseudoephedrine/Codeine Liquid has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your cough or other symptoms persist for more than 7 days, if they come back, or if you also have fever, rash, or persistent headache, check with your doctor.
• Do not use Pseudoephedrine/Codeine Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• Pseudoephedrine/Codeine Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pseudoephedrine/Codeine Liquid.
• Tell your doctor or dentist that you take Pseudoephedrine/Codeine Liquid before you receive any medical or dental care, emergency care, or surgery.
• Use Pseudoephedrine/Codeine Liquid with caution in the ELDERLY; they may be more sensitive to its effects.
• Pseudoephedrine/Codeine Liquid should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pseudoephedrine/Codeine Liquid, discuss with your doctor the benefits and risks of using Pseudoephedrine/Codeine Liquid during pregnancy. Pseudoephedrine/Codeine Liquid is found in breast milk. Do not breast-feed while taking Pseudoephedrine/Codeine Liquid.

When used for long periods of time or at high doses, Pseudoephedrine/Codeine Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Pseudoephedrine/Codeine Liquid stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Pseudoephedrine/Codeine Liquid. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Pseudoephedrine/Codeine Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; trouble sleeping.

Possible side effects of Pseudoephedrine/Codeine Liquid:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; stomach pain; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; difficulty urinating; fast, slow, or irregular heartbeat; hallucinations; loss of coordination; mental or mood changes; numbness or tingling of the skin; persistent loss of appetite; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shortness of breath; tremor; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; cold, clammy skin; confusion; fast, slow, or irregular heartbeat; hallucinations; pinpoint pupils; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; slow or difficult breathing; vomiting.

Proper storage of Pseudoephedrine/Codeine Liquid:

Store Pseudoephedrine/Codeine Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Codeine Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Codeine Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Codeine Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Codeine Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pseudoephedrine/

Codeine/

Guaifenesin Syrup

Generic Name: Codeine/Guaifenesin/Pseudoephedrine (KOE-deen/gwye-FEN-e-sin/SOO-doe-e-FED-rin)
Brand Name: Examples include Mytussin DAC and Robitussin DAC

Pseudoephedrine/Codeine/Guaifenesin Syrup is used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Codeine/Guaifenesin Syrup is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive.

Do NOT use Pseudoephedrine/Codeine/Guaifenesin Syrup if:

• you are allergic to any ingredient in Pseudoephedrine/Codeine/Guaifenesin Syrup or any other codeine- or morphine-related medicine (eg, oxycodone)
• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
• you are having an asthma attack
• you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Codeine/Guaifenesin Syrup:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, hydrocodone, dihydrocodeine, oxycodone)
• if you have a history of glaucoma; an enlarged prostate gland or other prostate problems; heart problems; diabetes; high blood pressure; blood vessel problems; stroke; liver or kidney problems; blockage of the stomach, bowel, or bladder; adrenal gland problems; or thyroid problems
• if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery
• if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if you have a cough that occurs with large amounts of mucus
• if you have a fever, severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)
• if you have very poor health or a history of alcohol abuse, other substance abuse, or suicidal thoughts or actions
• if you are taking medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Pseudoephedrine/Codeine/Guaifenesin Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pseudoephedrine/Codeine/Guaifenesin Syrup’s side effects
• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Pseudoephedrine/Codeine/Guaifenesin Syrup’s effectiveness
• Bromocriptine or sodium oxybate (GHB) because the risk of their side effects may be increased by Pseudoephedrine/Codeine/Guaifenesin Syrup
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Codeine/Guaifenesin Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Codeine/Guaifenesin Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Codeine/Guaifenesin Syrup:

• Take Pseudoephedrine/Codeine/Guaifenesin Syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Drink plenty of water while taking Pseudoephedrine/Codeine/Guaifenesin Syrup.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Pseudoephedrine/Codeine/Guaifenesin Syrup, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Codeine/Guaifenesin Syrup.

Important safety information:

• Pseudoephedrine/Codeine/Guaifenesin Syrup may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Codeine/Guaifenesin Syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Codeine/Guaifenesin Syrup; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Pseudoephedrine/Codeine/Guaifenesin Syrup may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Codeine/Guaifenesin Syrup without checking with your doctor.
• Pseudoephedrine/Codeine/Guaifenesin Syrup has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 days, if they get worse, or if they go away and then come back, check with your doctor.
• If your symptoms occur along with fever, rash, or persistent headache, contact your doctor.
• Do not use Pseudoephedrine/Codeine/Guaifenesin Syrup for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• Pseudoephedrine/Codeine/Guaifenesin Syrup may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Codeine/Guaifenesin Syrup. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Pseudoephedrine/Codeine/Guaifenesin Syrup may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pseudoephedrine/Codeine/Guaifenesin Syrup.
• Tell your doctor or dentist that you take Pseudoephedrine/Codeine/Guaifenesin Syrup before you receive any medical or dental care, emergency care, or surgery.
• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
• Use Pseudoephedrine/Codeine/Guaifenesin Syrup with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.
• Caution is advised when using Pseudoephedrine/Codeine/Guaifenesin Syrup in CHILDREN; they may be more sensitive to its effects, especially excitability.
• Pseudoephedrine/Codeine/Guaifenesin Syrup should not be used in CHILDREN younger than 6 years old without first checking with the child’s doctor; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Codeine/Guaifenesin Syrup while you are pregnant. Pseudoephedrine/Codeine/Guaifenesin Syrup is found in breast milk. Do not breast-feed while taking Pseudoephedrine/Codeine/Guaifenesin Syrup.

Possible side effects of Pseudoephedrine/Codeine/Guaifenesin Syrup:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow or rapid breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Codeine/Guaifenesin Syrup:

Store Pseudoephedrine/Codeine/Guaifenesin Syrup at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Codeine/Guaifenesin Syrup out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Codeine/Guaifenesin Syrup, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Codeine/Guaifenesin Syrup is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Codeine/Guaifenesin Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pseudoephedrine/

Codeine/

Guaifenesin

Generic Name: Codeine/Guaifenesin/Pseudoephedrine (KOE-deen/gwye-FEN-e-sin/SOO-doe-e-FED-rin)
Brand Name: Examples include Ambifed CD and Maxifed-G CDX

Pseudoephedrine/Codeine/Guaifenesin is used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Codeine/Guaifenesin is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive.

Do NOT use Pseudoephedrine/Codeine/Guaifenesin if:

• you are allergic to any ingredient in Pseudoephedrine/Codeine/Guaifenesin or any other codeine- or morphine-related medicine (eg, oxycodone)
• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
• you are having an asthma attack
• you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Codeine/Guaifenesin:

Some medical conditions may interact with Pseudoephedrine/Codeine/Guaifenesin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, dihydrocodeine, hydrocodone, oxycodone)
• if you have a history of glaucoma; an enlarged prostate gland or other prostate problems; heart problems; diabetes; high blood pressure; blood vessel problems; stroke; liver or kidney problems; blockage of the stomach, bowel, or bladder; adrenal gland problems; or thyroid problems
• if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery
• if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus
• if you have a fever, severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)
• if you have very poor health or a history of alcohol abuse, other substance abuse, or suicidal thoughts or actions
• if you are taking medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Pseudoephedrine/Codeine/Guaifenesin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pseudoephedrine/Codeine/Guaifenesin’s side effects
• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Pseudoephedrine/Codeine/Guaifenesin’s effectiveness
• Bromocriptine or sodium oxybate (GHB) because the risk of their side effects may be increased by Pseudoephedrine/Codeine/Guaifenesin
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Codeine/Guaifenesin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Codeine/Guaifenesin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Codeine/Guaifenesin:

Use Pseudoephedrine/Codeine/Guaifenesin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine/Codeine/Guaifenesin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Drink plenty of water while taking Pseudoephedrine/Codeine/Guaifenesin.
• If you miss a dose of Pseudoephedrine/Codeine/Guaifenesin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Codeine/Guaifenesin.

Important safety information:

• Pseudoephedrine/Codeine/Guaifenesin may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Codeine/Guaifenesin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Codeine/Guaifenesin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Pseudoephedrine/Codeine/Guaifenesin may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Codeine/Guaifenesin without checking with your doctor.
• Pseudoephedrine/Codeine/Guaifenesin has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 days, if they get worse, or if they go away and then come back, check with your doctor.
• If your symptoms occur along with fever, rash, or persistent headache, contact your doctor.
• Do not use Pseudoephedrine/Codeine/Guaifenesin for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• Pseudoephedrine/Codeine/Guaifenesin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Codeine/Guaifenesin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Pseudoephedrine/Codeine/Guaifenesin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pseudoephedrine/Codeine/Guaifenesin.
• Tell your doctor or dentist that you take Pseudoephedrine/Codeine/Guaifenesin before you receive any medical or dental care, emergency care, or surgery.
• Use Pseudoephedrine/Codeine/Guaifenesin with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.
• Caution is advised when using Pseudoephedrine/Codeine/Guaifenesin in CHILDREN; they may be more sensitive to its effects, especially excitability.
• Pseudoephedrine/Codeine/Guaifenesin should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Codeine/Guaifenesin while you are pregnant. Pseudoephedrine/Codeine/Guaifenesin is found in breast milk. Do not breast-feed while taking Pseudoephedrine/Codeine/Guaifenesin.

Possible side effects of Pseudoephedrine/Codeine/Guaifenesin:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow or rapid breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Codeine/Guaifenesin:

Store Pseudoephedrine/Codeine/Guaifenesin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Codeine/Guaifenesin out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Codeine/Guaifenesin, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Codeine/Guaifenesin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Codeine/Guaifenesin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pseudoephedrine/

Codeine/

Guaifenesin Suspension

Generic Name: Pseudoephedrine/Codeine/Guaifenesin (SOO-doe-e-FED-rin/KOE-deen/gwye-FEN-e-sin)
Brand Name: Zodryl DEC

Pseudoephedrine/Codeine/Guaifenesin Suspension is used for:

Relieving congestion and cough caused by colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Codeine/Guaifenesin Suspension is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive.

Do NOT use Pseudoephedrine/Codeine/Guaifenesin Suspension if:

• you are allergic to any ingredient in Pseudoephedrine/Codeine/Guaifenesin Suspension or any other codeine- or morphine-related medicine (eg, oxycodone)
• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
• you are having an asthma attack
• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Codeine/Guaifenesin Suspension:

Some medical conditions may interact with Pseudoephedrine/Codeine/Guaifenesin Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, hydrocodone, dihydrocodeine, oxycodone)
• if you have a history of glaucoma; an enlarged prostate gland or other prostate problems; heart problems; diabetes; high blood pressure; blood vessel problems; stroke; liver or kidney problems; blockage of the stomach, bowel, or bladder; adrenal gland problems; or thyroid problems
• if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or you have had recent stomach, bowel, or urinary surgery
• if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), or you have a cough that occurs with large amounts of mucus
• if you have a fever, severe drowsiness, a recent head or brain injury, a brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)
• if you have very poor health or a history of alcohol abuse, other substance abuse, or suicidal thoughts or actions
• if you are taking medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Pseudoephedrine/Codeine/Guaifenesin Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, linezolid, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pseudoephedrine/Codeine/Guaifenesin Suspension’s side effects
• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Pseudoephedrine/Codeine/Guaifenesin Suspension’s effectiveness
• Bromocriptine or sodium oxybate (GHB) because the risk of their side effects may be increased by Pseudoephedrine/Codeine/Guaifenesin Suspension
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Codeine/Guaifenesin Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Codeine/Guaifenesin Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Codeine/Guaifenesin Suspension:

Use Pseudoephedrine/Codeine/Guaifenesin Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine/Codeine/Guaifenesin Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Shake well before each use.
• Use the measuring device that comes with Pseudoephedrine/Codeine/Guaifenesin Suspension to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Drink plenty of water while taking Pseudoephedrine/Codeine/Guaifenesin Suspension.
• If you miss a dose of Pseudoephedrine/Codeine/Guaifenesin Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Codeine/Guaifenesin Suspension.

Important safety information:

• Pseudoephedrine/Codeine/Guaifenesin Suspension may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Codeine/Guaifenesin Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Codeine/Guaifenesin Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Pseudoephedrine/Codeine/Guaifenesin Suspension may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Codeine/Guaifenesin Suspension without checking with your doctor.
• Pseudoephedrine/Codeine/Guaifenesin Suspension has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 days, if they get worse, or if they go away and then come back, check with your doctor.
• If your symptoms occur along with fever, rash, or persistent headache, contact your doctor.
• Do not use Pseudoephedrine/Codeine/Guaifenesin Suspension for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• Pseudoephedrine/Codeine/Guaifenesin Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Codeine/Guaifenesin Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Pseudoephedrine/Codeine/Guaifenesin Suspension may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pseudoephedrine/Codeine/Guaifenesin Suspension.
• Tell your doctor or dentist that you take Pseudoephedrine/Codeine/Guaifenesin Suspension before you receive any medical or dental care, emergency care, or surgery.
• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
• Use Pseudoephedrine/Codeine/Guaifenesin Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.
• Caution is advised when using Pseudoephedrine/Codeine/Guaifenesin Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.
• Pseudoephedrine/Codeine/Guaifenesin Suspension should not be used in CHILDREN younger than 6 years old without first checking with the child’s doctor; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Codeine/Guaifenesin Suspension while you are pregnant. Pseudoephedrine/Codeine/Guaifenesin Suspension is found in breast milk. Do not breast-feed while taking Pseudoephedrine/Codeine/Guaifenesin Suspension.

Some people who use Pseudoephedrine/Codeine/Guaifenesin Suspension for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Pseudoephedrine/Codeine/Guaifenesin Suspension suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, irregular heartbeat, irritability, restlessness, trouble sleeping, and unusual sweating.

Possible side effects of Pseudoephedrine/Codeine/Guaifenesin Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow or rapid breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Codeine/Guaifenesin Suspension:

Store Pseudoephedrine/Codeine/Guaifenesin Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Codeine/Guaifenesin Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Codeine/Guaifenesin Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Codeine/Guaifenesin Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Codeine/Guaifenesin Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pseudoephedrine/

Dextromethorphan Chewable Tablets

Generic Name: Pseudoephedrine/Dextromethorphan (sue-do-eh-FED-rin/dex-troe-meth-OR-fan)
Brand Name: PediaCare Long-Acting Cough/Cold

Pseudoephedrine/Dextromethorphan Chewable Tablets are used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Dextromethorphan Chewable Tablets are a decongestant and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you to breathe more easily. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Pseudoephedrine/Dextromethorphan Chewable Tablets if:

• you are allergic to any ingredient in Pseudoephedrine/Dextromethorphan Chewable Tablets
• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Dextromethorphan Chewable Tablets:

Some medical conditions may interact with Pseudoephedrine/Dextromethorphan Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, or stroke
• if you have chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Pseudoephedrine/Dextromethorphan Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Pseudoephedrine/Dextromethorphan Chewable Tablets may be increased
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine because the risk of side effects may be increased by Pseudoephedrine/Dextromethorphan Chewable Tablets
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Dextromethorphan Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Dextromethorphan Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Dextromethorphan Chewable Tablets:

Use Pseudoephedrine/Dextromethorphan Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pseudoephedrine/Dextromethorphan Chewable Tablets may be taken with or without food.
• Chew thoroughly before swallowing.
• If you miss a dose of Pseudoephedrine/Dextromethorphan Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Dextromethorphan Chewable Tablets.

Important safety information:

• Pseudoephedrine/Dextromethorphan Chewable Tablets may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pseudoephedrine/Dextromethorphan Chewable Tablets. Using Pseudoephedrine/Dextromethorphan Chewable Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take appetite suppressants while you are taking Pseudoephedrine/Dextromethorphan Chewable Tablets without checking with your doctor.
• Pseudoephedrine/Dextromethorphan Chewable Tablets contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Pseudoephedrine/Dextromethorphan Chewable Tablets for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Pseudoephedrine/Dextromethorphan Chewable Tablets may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Pseudoephedrine/Dextromethorphan Chewable Tablets.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Pseudoephedrine/Dextromethorphan Chewable Tablets.
• Use Pseudoephedrine/Dextromethorphan Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Pseudoephedrine/Dextromethorphan Chewable Tablets in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pseudoephedrine/Dextromethorphan Chewable Tablets, discuss with your doctor the benefits and risks of using Pseudoephedrine/Dextromethorphan Chewable Tablets during pregnancy. It is unknown if Pseudoephedrine/Dextromethorphan Chewable Tablets are excreted in breast milk. Do not breast-feed while taking Pseudoephedrine/Dextromethorphan Chewable Tablets.

Possible side effects of Pseudoephedrine/Dextromethorphan Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Dextromethorphan Chewable Tablets:

Store Pseudoephedrine/Dextromethorphan Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Dextromethorphan Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Dextromethorphan Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Dextromethorphan Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Dextromethorphan Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pseudoephedrine/

Dextromethorphan Elixir

Generic Name: Pseudoephedrine/Dextromethorphan (sue-do-eh-FED-rin/dex-troe-meth-OR-fan)
Brand Name: Examples include Dexatrex D and Tussin Pediatric

Pseudoephedrine/Dextromethorphan Elixir is used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Dextromethorphan Elixir is a decongestant and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you to breathe more easily. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Pseudoephedrine/Dextromethorphan Elixir if:

• you are allergic to any ingredient in Pseudoephedrine/Dextromethorphan Elixir
• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Dextromethorphan Elixir:

Some medical conditions may interact with Pseudoephedrine/Dextromethorphan Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, or stroke
• if you have chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Pseudoephedrine/Dextromethorphan Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Pseudoephedrine/Dextromethorphan Elixir may be increased
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine because the risk of side effects may be increased by Pseudoephedrine/Dextromethorphan Elixir
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Dextromethorphan Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Dextromethorphan Elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Dextromethorphan Elixir:

Use Pseudoephedrine/Dextromethorphan Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pseudoephedrine/Dextromethorphan Elixir may be taken with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Pseudoephedrine/Dextromethorphan Elixir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Dextromethorphan Elixir.

Important safety information:

• Pseudoephedrine/Dextromethorphan Elixir may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pseudoephedrine/Dextromethorphan Elixir. Using Pseudoephedrine/Dextromethorphan Elixir alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take appetite suppressants while you are taking Pseudoephedrine/Dextromethorphan Elixir without checking with your doctor.
• Pseudoephedrine/Dextromethorphan Elixir contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Pseudoephedrine/Dextromethorphan Elixir for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Pseudoephedrine/Dextromethorphan Elixir may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Pseudoephedrine/Dextromethorphan Elixir.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Pseudoephedrine/Dextromethorphan Elixir.
• Use Pseudoephedrine/Dextromethorphan Elixir with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Pseudoephedrine/Dextromethorphan Elixir in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pseudoephedrine/Dextromethorphan Elixir, discuss with your doctor the benefits and risks of using Pseudoephedrine/Dextromethorphan Elixir during pregnancy. It is unknown if Pseudoephedrine/Dextromethorphan Elixir is excreted in breast milk. Do not breast-feed while taking Pseudoephedrine/Dextromethorphan Elixir.

Possible side effects of Pseudoephedrine/Dextromethorphan Elixir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Dextromethorphan Elixir:

Store Pseudoephedrine/Dextromethorphan Elixir at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Dextromethorphan Elixir out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Dextromethorphan Elixir, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Dextromethorphan Elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Dextromethorphan Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Pseudoephedrine/

Dextromethorphan Drops

Generic Name: Pseudoephedrine/Dextromethorphan (sue-do-eh-FED-rin/dex-troe-meth-OR-fan)
Brand Name: Examples include Dimetapp Decongestant Plus Cough Infant Drops and Pedia Relief Infant

Pseudoephedrine/Dextromethorphan Drops are used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Dextromethorphan Drops are a decongestant and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you to breathe more easily. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Pseudoephedrine/Dextromethorphan Drops if:

• you are allergic to any ingredient in Pseudoephedrine/Dextromethorphan Drops
• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Dextromethorphan Drops:

Some medical conditions may interact with Pseudoephedrine/Dextromethorphan Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, or stroke
• if you have chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Pseudoephedrine/Dextromethorphan Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Pseudoephedrine/Dextromethorphan Drops may be increased
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine because the risk of side effects may be increased by Pseudoephedrine/Dextromethorphan Drops
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Dextromethorphan Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Dextromethorphan Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Dextromethorphan Drops:

Use Pseudoephedrine/Dextromethorphan Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pseudoephedrine/Dextromethorphan Drops may be taken with or without food.
• Use the dropper that comes with Pseudoephedrine/Dextromethorphan Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Pseudoephedrine/Dextromethorphan Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Dextromethorphan Drops.

Important safety information:

• Pseudoephedrine/Dextromethorphan Drops may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pseudoephedrine/Dextromethorphan Drops. Using Pseudoephedrine/Dextromethorphan Drops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take appetite suppressants while you are taking Pseudoephedrine/Dextromethorphan Drops without checking with your doctor.
• Pseudoephedrine/Dextromethorphan Drops contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Pseudoephedrine/Dextromethorphan Drops for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Pseudoephedrine/Dextromethorphan Drops may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Pseudoephedrine/Dextromethorphan Drops.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Pseudoephedrine/Dextromethorphan Drops.
• Use Pseudoephedrine/Dextromethorphan Drops with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Pseudoephedrine/Dextromethorphan Drops in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pseudoephedrine/Dextromethorphan Drops, discuss with your doctor the benefits and risks of using Pseudoephedrine/Dextromethorphan Drops during pregnancy. It is unknown if Pseudoephedrine/Dextromethorphan Drops are excreted in breast milk. Do not breast-feed while taking Pseudoephedrine/Dextromethorphan Drops.

Possible side effects of Pseudoephedrine/Dextromethorphan Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Dextromethorphan Drops:

Store Pseudoephedrine/Dextromethorphan Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Dextromethorphan Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Dextromethorphan Drops, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Dextromethorphan Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pseudoephedrine/Dextromethorphan Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.