Pseudoephedrine/

Ibuprofen

Generic Name: Pseudoephedrine/Ibuprofen (SOO-doe-e-FED-rin/EYE-bue-PROE-fen)
Brand Name: Examples include Advil Cold and Sinus Caplets and Advil Cold and Sinus Liqui-Gels

Pseudoephedrine/Ibuprofen is used for:

Relieving symptoms such as pain and sinus congestion due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Pseudoephedrine/Ibuprofen is an analgesic and decongestant combination. The analgesic works in the brain to help decrease pain. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.

Do NOT use Pseudoephedrine/Ibuprofen if:

• you are allergic to any ingredient in Pseudoephedrine/Ibuprofen
• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, celecoxib, ibuprofen)
• you have recently had or will be having bypass heart surgery
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
• you are in the last 3 months of pregnancy

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

Before using Pseudoephedrine/Ibuprofen:

Some medical conditions may interact with Pseudoephedrine/Ibuprofen. 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), asthma, stomach or bowel problems (eg, bleeding, perforation, ulcers, persistent or returning stomach pain or heartburn), heart problems (eg, heart failure), high blood pressure, diabetes, blood disorders, bleeding or clotting problems, blood vessel problems, stroke, glaucoma or increased eye pressure, an enlarged prostate or other prostate problems, seizures, an overactive thyroid, kidney problems, or liver problems (eg, hepatitis), or if you are at risk for any of these diseases
• if you have a history of swelling or fluid buildup, lupus, asthma, growths in the nose (nasal polyps), or mouth inflammation
• if you are dehydrated or have low fluid volume (eg, caused by diarrhea, not drinking fluids, vomiting)
• if you have poor health or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

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

• Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased
• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), probenecid, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pseudoephedrine/Ibuprofen’s side effects
• Bromocriptine, cyclosporine, hydantoins (eg, phenytoin), lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Pseudoephedrine/Ibuprofen
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) diuretics (eg, furosemide, hydrochlorothiazide), guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Ibuprofen

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Ibuprofen 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/Ibuprofen:

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

• Take Pseudoephedrine/Ibuprofen by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
• Take Pseudoephedrine/Ibuprofen with a full glass of water (8 oz/240 mL) as directed by your doctor.
• If you miss a dose of Pseudoephedrine/Ibuprofen, 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/Ibuprofen.

Important safety information:

• Pseudoephedrine/Ibuprofen may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Ibuprofen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Serious stomach ulcers or bleeding can occur with the use of Pseudoephedrine/Ibuprofen. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Pseudoephedrine/Ibuprofen with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
• Talk to your doctor before you take Pseudoephedrine/Ibuprofen if you drink more than 3 drinks with alcohol per day.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Ibuprofen without checking with you doctor.
• Pseudoephedrine/Ibuprofen has ibuprofen and pseudoephedrine in it. Before you start any new medicine, check the label to see if it has ibuprofen or 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 condition does not get better within 7 days or you have a fever that does not get better within 3 days, check with your doctor. If your symptoms get worse or if you have new symptoms, check with your doctor.
• Check with your doctor if you have a severe or persistent sore throat or if you have a sore throat with fever, headache, nausea, and vomiting.
• Tell your doctor or dentist that you take Pseudoephedrine/Ibuprofen before you receive any medical or dental care, emergency care, or surgery.
• Do not take aspirin while you are taking Pseudoephedrine/Ibuprofen unless your doctor tells you to.
• Use Pseudoephedrine/Ibuprofen with caution in the ELDERLY; they may be more sensitive to its effects.
• Pseudoephedrine/Ibuprofen should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Ibuprofen while you are pregnant. Do not take Pseudoephedrine/Ibuprofen during the last 3 months of pregnancy. It may cause injury or death to the fetus. If you become pregnant, contact your doctor right away. Pseudoephedrine/Ibuprofen is excreted in breast milk. If you are or will be breast-feeding while you use Pseudoephedrine/Ibuprofen, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Pseudoephedrine/Ibuprofen:

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; 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); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; tremor; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of skin or eyes.

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; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; unusually fast, slow, or irregular heartbeat; vomit that looks like coffee grounds.

Proper storage of Pseudoephedrine/Ibuprofen:

Store Pseudoephedrine/Ibuprofen at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Ibuprofen out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Ibuprofen, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Ibuprofen 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/Ibuprofen. 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/

Methscopolamine Sustained-Release Tablets

Generic Name: Pseudoephedrine/Methscopolamine (SOO-doe-e-FED-rin/METH-skoe-POL-a-meen with KLOR-fen-IR-a-meen/METH-skoe-POL-a-meen)
Brand Name: VisRx

Pseudoephedrine/Methscopolamine Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes caused by allergies or the common cold. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Methscopolamine Sustained-Release Tablets are a combination pack containing a morning dose and an evening dose. The morning dose has a decongestant and an anticholinergic medicine. The evening dose has an antihistamine and an anticholinergic medicine. The decongestant works by shrinking swollen tissue in the nose. The antihistamine works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. The anticholinergic works by drying mucous membranes in the nose and chest.

Do NOT use Pseudoephedrine/Methscopolamine Sustained-Release Tablets if:

• you are allergic to any ingredient in Pseudoephedrine/Methscopolamine Sustained-Release Tablets
• you are breast-feeding
• you are taking droxidopa, furazolidone, a phosphodiesterase inhibitor (eg, sildenafil), sodium oxybate (GHB), or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days
• you have severe heart blood vessel problems, severe high blood pressure, narrow-angle glaucoma, difficulty urinating, or peptic ulcer
• you are having an asthma attack

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

Before using Pseudoephedrine/Methscopolamine Sustained-Release Tablets:

Some medical conditions may interact with Pseudoephedrine/Methscopolamine Sustained-Release 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 are taking or have taken medicine for high blood pressure or depression in the last 14 days
• if you have a bladder blockage, an enlarged prostate, or trouble urinating
• if you have blood vessel problems (eg, hardening of the arteries), diabetes, glaucoma, heart problems (eg, irregular heartbeat, heart failure), high blood pressure, kidney problems, liver problems, lung or breathing problems (eg asthma, sleep apnea), a hiatal hernia, an adrenal gland tumor (pheochromocytoma), myasthenia gravis (muscle weakness), nerve problems (eg, neuropathy), stomach or bowel problems (eg, constipation, ulcerative colitis, motility problems, blockage), trouble sleeping, or an overactive thyroid
• if you have a history of alcohol abuse
• if you take potassium chloride tablets or capsules

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

• Droxidopa or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased
• Alkalinizers (eg, sodium bicarbonate), anticholinergics (eg, benztropine, dicyclomine), antipsychotics (eg, chlorpromazine), beta-blockers (eg, propranolol), carbonic anhydrase inhibitors (eg, acetazolamide), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, MAOIs (eg, phenelzine), phosphodiesterase inhibitors (eg, sildenafil), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pseudoephedrine/Methscopolamine Sustained-Release Tablets’s side effects
• Bromocriptine or digoxin because the risk of their side effects may be increased by Pseudoephedrine/Methscopolamine Sustained-Release Tablets
• Guanadrel, guanethidine, mecamylamine, methyldopa, reserpine, or other medicines for high blood pressure because their effectiveness may be decreased by Pseudoephedrine/Methscopolamine Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Methscopolamine Sustained-Release 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/Methscopolamine Sustained-Release Tablets:

Use Pseudoephedrine/Methscopolamine Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine/Methscopolamine Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Pseudoephedrine/Methscopolamine Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.
• This product contains 2 different tablets: one for the morning and one for the evening. Be sure you understand how to take Pseudoephedrine/Methscopolamine Sustained-Release Tablets. Check with your doctor or pharmacist if you are not sure which tablet to take in the morning or in the evening.
• Do not take Pseudoephedrine/Methscopolamine Sustained-Release Tablets at the same time as antacids, certain medicines for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole. Take these medicines 2 or 3 hours before or after taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets.
• If you miss a dose of Pseudoephedrine/Methscopolamine Sustained-Release Tablets 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/Methscopolamine Sustained-Release Tablets.

Important safety information:

• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Methscopolamine Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Methscopolamine Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets.
• Pseudoephedrine/Methscopolamine Sustained-Release 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/Methscopolamine Sustained-Release Tablets for a few days before the tests.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets contains the stimulant pseudoephedrine. Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets without checking with your doctor.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets has a decongestant and an antihistamine in it. Before you start any new medicine, check the label to see if it has a decongestant or an antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Diabetes patients – Pseudoephedrine/Methscopolamine Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Use Pseudoephedrine/Methscopolamine Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Pseudoephedrine/Methscopolamine Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Methscopolamine Sustained-Release Tablets while you are pregnant. Pseudoephedrine/Methscopolamine Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets.

When used for long periods of time, Pseudoephedrine/Methscopolamine Sustained-Release Tablets may not work as well. This is known as TOLERANCE. Increasing the dose may cause toxic side effects to occur.

If you suddenly stop taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets, WITHDRAWAL symptoms, including worsening of congestion, may occur.

Possible side effects of Pseudoephedrine/Methscopolamine Sustained-Release 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:

Blurred vision; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); headache; lack of energy; lightheadedness; nausea; nervousness; 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); fast or irregular heartbeat; flushing; hallucinations; mental or mood changes (eg, anxiety); seizures; severe or persistent drowsiness or dizziness; tremor; trouble urinating; unusual tiredness or weakness.

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 deep sleep or loss of consciousness; hot or cool skin; fast or irregular heartbeat; large pupils; seizures; severe irritability, anxiety, or panicked feeling; slowed or shallow breathing; vomiting.

Proper storage of Pseudoephedrine/Methscopolamine Sustained-Release Tablets:

Store Pseudoephedrine/Methscopolamine Sustained-Release Tablets 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/Methscopolamine Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Methscopolamine Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Methscopolamine Sustained-Release 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/Methscopolamine Sustained-Release 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/

Methscopolamine Sustained-Release Tablets

Generic Name: Pseudoephedrine/Methscopolamine (SOO-doe-e-FED-rin/METH-skoe-POL-a-meen with KLOR-fen-IR-a-meen/METH-skoe-POL-a-meen)
Brand Name: VisRx

Pseudoephedrine/Methscopolamine Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes caused by allergies or the common cold. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Methscopolamine Sustained-Release Tablets are a combination pack containing a morning dose and an evening dose. The morning dose has a decongestant and an anticholinergic medicine. The evening dose has an antihistamine and an anticholinergic medicine. The decongestant works by shrinking swollen tissue in the nose. The antihistamine works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. The anticholinergic works by drying mucous membranes in the nose and chest.

Do NOT use Pseudoephedrine/Methscopolamine Sustained-Release Tablets if:

• you are allergic to any ingredient in Pseudoephedrine/Methscopolamine Sustained-Release Tablets
• you are breast-feeding
• you are taking droxidopa, furazolidone, a phosphodiesterase inhibitor (eg, sildenafil), sodium oxybate (GHB), or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days
• you have severe heart blood vessel problems, severe high blood pressure, narrow-angle glaucoma, difficulty urinating, or peptic ulcer
• you are having an asthma attack

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

Before using Pseudoephedrine/Methscopolamine Sustained-Release Tablets:

Some medical conditions may interact with Pseudoephedrine/Methscopolamine Sustained-Release 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 are taking or have taken medicine for high blood pressure or depression in the last 14 days
• if you have a bladder blockage, an enlarged prostate, or trouble urinating
• if you have blood vessel problems (eg, hardening of the arteries), diabetes, glaucoma, heart problems (eg, irregular heartbeat, heart failure), high blood pressure, kidney problems, liver problems, lung or breathing problems (eg asthma, sleep apnea), a hiatal hernia, an adrenal gland tumor (pheochromocytoma), myasthenia gravis (muscle weakness), nerve problems (eg, neuropathy), stomach or bowel problems (eg, constipation, ulcerative colitis, motility problems, blockage), trouble sleeping, or an overactive thyroid
• if you have a history of alcohol abuse
• if you take potassium chloride tablets or capsules

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

• Droxidopa or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased
• Alkalinizers (eg, sodium bicarbonate), anticholinergics (eg, benztropine, dicyclomine), antipsychotics (eg, chlorpromazine), beta-blockers (eg, propranolol), carbonic anhydrase inhibitors (eg, acetazolamide), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, MAOIs (eg, phenelzine), phosphodiesterase inhibitors (eg, sildenafil), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pseudoephedrine/Methscopolamine Sustained-Release Tablets’s side effects
• Bromocriptine or digoxin because the risk of their side effects may be increased by Pseudoephedrine/Methscopolamine Sustained-Release Tablets
• Guanadrel, guanethidine, mecamylamine, methyldopa, reserpine, or other medicines for high blood pressure because their effectiveness may be decreased by Pseudoephedrine/Methscopolamine Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Methscopolamine Sustained-Release 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/Methscopolamine Sustained-Release Tablets:

Use Pseudoephedrine/Methscopolamine Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine/Methscopolamine Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Pseudoephedrine/Methscopolamine Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.
• This product contains 2 different tablets: one for the morning and one for the evening. Be sure you understand how to take Pseudoephedrine/Methscopolamine Sustained-Release Tablets. Check with your doctor or pharmacist if you are not sure which tablet to take in the morning or in the evening.
• Do not take Pseudoephedrine/Methscopolamine Sustained-Release Tablets at the same time as antacids, certain medicines for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole. Take these medicines 2 or 3 hours before or after taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets.
• If you miss a dose of Pseudoephedrine/Methscopolamine Sustained-Release Tablets 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/Methscopolamine Sustained-Release Tablets.

Important safety information:

• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Methscopolamine Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pseudoephedrine/Methscopolamine Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets.
• Pseudoephedrine/Methscopolamine Sustained-Release 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/Methscopolamine Sustained-Release Tablets for a few days before the tests.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets contains the stimulant pseudoephedrine. Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets without checking with your doctor.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets has a decongestant and an antihistamine in it. Before you start any new medicine, check the label to see if it has a decongestant or an antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Diabetes patients – Pseudoephedrine/Methscopolamine Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Use Pseudoephedrine/Methscopolamine Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Pseudoephedrine/Methscopolamine Sustained-Release Tablets should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Pseudoephedrine/Methscopolamine Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Methscopolamine Sustained-Release Tablets while you are pregnant. Pseudoephedrine/Methscopolamine Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets.

When used for long periods of time, Pseudoephedrine/Methscopolamine Sustained-Release Tablets may not work as well. This is known as TOLERANCE. Increasing the dose may cause toxic side effects to occur.

If you suddenly stop taking Pseudoephedrine/Methscopolamine Sustained-Release Tablets, WITHDRAWAL symptoms, including worsening of congestion, may occur.

Possible side effects of Pseudoephedrine/Methscopolamine Sustained-Release 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:

Blurred vision; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); headache; lack of energy; lightheadedness; nausea; nervousness; 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); fast or irregular heartbeat; flushing; hallucinations; mental or mood changes (eg, anxiety); seizures; severe or persistent drowsiness or dizziness; tremor; trouble urinating; unusual tiredness or weakness.

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 deep sleep or loss of consciousness; hot or cool skin; fast or irregular heartbeat; large pupils; seizures; severe irritability, anxiety, or panicked feeling; slowed or shallow breathing; vomiting.

Proper storage of Pseudoephedrine/Methscopolamine Sustained-Release Tablets:

Store Pseudoephedrine/Methscopolamine Sustained-Release Tablets 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/Methscopolamine Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Methscopolamine Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Methscopolamine Sustained-Release 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/Methscopolamine Sustained-Release 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/

Pyrilamine/

Carbetapentane Liquid

Generic Name: Pseudoephedrine/Pyrilamine/Carbetapentane (SOO-doe-e-FED-rin/pir-IL-a-meen/kar-bay-ta-PEN-tane)
Brand Name: Zotex-D

Pseudoephedrine/Pyrilamine/Carbetapentane Liquid is used for:

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

Pseudoephedrine/Pyrilamine/Carbetapentane Liquid is a decongestant, antihistamine, and cough suppressant combination. It 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/Pyrilamine/Carbetapentane Liquid if:

• you are allergic to any ingredient in Pseudoephedrine/Pyrilamine/Carbetapentane Liquid
• 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 take 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/Pyrilamine/Carbetapentane Liquid:

Some medical conditions may interact with Pseudoephedrine/Pyrilamine/Carbetapentane 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 a fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems (eg, ischemic heart disease); 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; mental or mood problems (eg, depression); sleep apnea; 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 are in poor health or are very overweight

Some MEDICINES MAY INTERACT with Pseudoephedrine/Pyrilamine/Carbetapentane Liquid. 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), furazolidone, MAOIs (eg, phenelzine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, potassium citrate) because they may increase the risk of Pseudoephedrine/Pyrilamine/Carbetapentane Liquid’s side effects
• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Pseudoephedrine/Pyrilamine/Carbetapentane Liquid
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Pyrilamine/Carbetapentane Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Pyrilamine/Carbetapentane 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/Pyrilamine/Carbetapentane Liquid:

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

• Take Pseudoephedrine/Pyrilamine/Carbetapentane Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take Pseudoephedrine/Pyrilamine/Carbetapentane Liquid with a full glass of water (8 oz/240 mL).
• Drink plenty of water while taking Pseudoephedrine/Pyrilamine/Carbetapentane Liquid.
• 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/Pyrilamine/Carbetapentane Liquid, 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/Pyrilamine/Carbetapentane Liquid.

Important safety information:

• Pseudoephedrine/Pyrilamine/Carbetapentane Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Pyrilamine/Carbetapentane 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/Pyrilamine/Carbetapentane 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 take Pseudoephedrine/Pyrilamine/Carbetapentane Liquid without checking with your doctor.
• Pseudoephedrine/Pyrilamine/Carbetapentane Liquid has pseudoephedrine, pyrilamine, and carbetapentane in it. Before you start any new medicine, check the label to see if it has pseudoephedrine, pyrilamine, or carbetapentane in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not use Pseudoephedrine/Pyrilamine/Carbetapentane 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.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.
• Pseudoephedrine/Pyrilamine/Carbetapentane Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Pyrilamine/Carbetapentane Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Pseudoephedrine/Pyrilamine/Carbetapentane Liquid 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/Pyrilamine/Carbetapentane Liquid for a few days before the tests.
• Tell your doctor or dentist that you take Pseudoephedrine/Pyrilamine/Carbetapentane Liquid before you receive any medical or dental care, emergency care, or surgery.
• Use Pseudoephedrine/Pyrilamine/Carbetapentane Liquid with caution in the ELDERLY; they may be more sensitive to its effects.
• Pseudoephedrine/Pyrilamine/Carbetapentane Liquid should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• Caution is advised when using Pseudoephedrine/Pyrilamine/Carbetapentane Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Pyrilamine/Carbetapentane Liquid while you are pregnant. It is not known if Pseudoephedrine/Pyrilamine/Carbetapentane Liquid is found in breast milk. If you are or will be breast-feeding while you use Pseudoephedrine/Pyrilamine/Carbetapentane Liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Pseudoephedrine/Pyrilamine/Carbetapentane 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:

Diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; indigestion; loss of appetite; nausea; nervousness; 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); chest pain or tightness; difficult or painful urination, inability to urinate, or changes in the amount of urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; increased trouble sleeping; mental or mood changes; seizures; severe dryness of mouth, nose, and throat; severe or persistent dizziness, drowsiness, lightheadedness, or headache; shortness of breath; tremor; vision changes (eg, blurred or double 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; decreased coordination or loss of balance; flushing or redness of the face; hallucinations; muscle spasms; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent stomach cramping with nausea or vomiting; unusually fast, slow, or irregular heartbeat.

Proper storage of Pseudoephedrine/Pyrilamine/Carbetapentane Liquid:

Store Pseudoephedrine/Pyrilamine/Carbetapentane 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/Pyrilamine/Carbetapentane Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Pyrilamine/Carbetapentane Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Pyrilamine/Carbetapentane 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/Pyrilamine/Carbetapentane 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/

Pyrilamine/

Codeine Syrup

Generic Name: Pseudoephedrine/Pyrilamine/Codeine (SOO-doe-e-FED-rin/pir-IL-a-meen/KOE-deen)
Brand Name: Neo AC

Pseudoephedrine/Pyrilamine/Codeine Syrup is used for:

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

Pseudoephedrine/Pyrilamine/Codeine Syrup 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/Pyrilamine/Codeine Syrup if:

• you are allergic to any ingredient in Pseudoephedrine/Pyrilamine/Codeine Syrup or any other codeine- or morphine-related medicine (eg, codeine, oxycodone)
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, stomach ulcer, narrow-angle glaucoma, difficulty urinating, or you are having an asthma attack
• you take 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/Pyrilamine/Codeine Syrup:

Some medical conditions may interact with Pseudoephedrine/Pyrilamine/Codeine Syrup. 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 (eg, heart disease); high or low blood pressure; low blood volume; diabetes; blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; trouble urinating; an enlarged prostate or other prostate problems; mental or mood problems (eg, depression); pancreas problems (eg, pancreatitis); thyroid problems
• if you have a history of asthma or other breathing problems, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or your cough occurs with large amounts of mucus
• if you have 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 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 a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior; or you are in poor health or are very overweight
• if you take medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Pseudoephedrine/Pyrilamine/Codeine Syrup. 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), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), linezolid, MAOIs (eg, phenelzine), muscle relaxants (eg, cyclobenzaprine), opioid analgesics (eg, hydrocodone), phenothiazines (eg, chlorpromazine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pseudoephedrine/Pyrilamine/Codeine Syrup’s side effects
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Pseudoephedrine/Pyrilamine/Codeine Syrup’s effectiveness
• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Pseudoephedrine/Pyrilamine/Codeine Syrup
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Pyrilamine/Codeine Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Pyrilamine/Codeine 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/Pyrilamine/Codeine Syrup:

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

• Take Pseudoephedrine/Pyrilamine/Codeine Syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take Pseudoephedrine/Pyrilamine/Codeine Syrup with a full glass of water (8 oz/240 mL).
• Drink plenty of water while taking Pseudoephedrine/Pyrilamine/Codeine 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/Pyrilamine/Codeine 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/Pyrilamine/Codeine Syrup.

Important safety information:

• Pseudoephedrine/Pyrilamine/Codeine Syrup may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Pyrilamine/Codeine Syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Pseudoephedrine/Pyrilamine/Codeine 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 drink alcohol or use medicines that may cause drowsiness (eg, muscle relaxers, sleep aids) while you are using Pseudoephedrine/Pyrilamine/Codeine Syrup; 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/Pyrilamine/Codeine Syrup without checking with your doctor.
• Pseudoephedrine/Pyrilamine/Codeine Syrup has pseudoephedrine and brompheniramine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine or brompheniramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not use Pseudoephedrine/Pyrilamine/Codeine 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.
• 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/Pyrilamine/Codeine Syrup may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Pyrilamine/Codeine Syrup. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Pseudoephedrine/Pyrilamine/Codeine Syrup 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/Pyrilamine/Codeine Syrup for a few days before the tests.
• Tell your doctor or dentist that you take Pseudoephedrine/Pyrilamine/Codeine Syrup before you receive any medical or dental care, emergency care, or surgery.
• Use Pseudoephedrine/Pyrilamine/Codeine 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/Pyrilamine/Codeine Syrup in CHILDREN; they may be more sensitive to its effects, especially excitability.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Pyrilamine/Codeine Syrup while you are pregnant. Do not take Pseudoephedrine/Pyrilamine/Codeine Syrup in the third trimester of pregnancy. It is not known if Pseudoephedrine/Pyrilamine/Codeine Syrup is found in breast milk. Do not breast-feed while taking Pseudoephedrine/Pyrilamine/Codeine Syrup.

Some people who use Pseudoephedrine/Pyrilamine/Codeine Syrup 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/Pyrilamine/Codeine Syrup suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, irregular heartbeat, irritability, restlessness, trouble sleeping, and unusual sweating.

Possible side effects of Pseudoephedrine/Pyrilamine/Codeine 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; 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); confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; hallucinations; loss of coordination; mental or mood changes (eg, irritability); ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; trouble sleeping; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness; vision changes or 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; cold and clammy skin; coma; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Pyrilamine/Codeine Syrup:

Store Pseudoephedrine/Pyrilamine/Codeine 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/Pyrilamine/Codeine Syrup out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Pyrilamine/Codeine Syrup, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Pyrilamine/Codeine 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/Pyrilamine/Codeine 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/

Triprolidine

Generic Name: Pseudoephedrine/Triprolidine (soo-doe-e-FED-rin/try-PRO-li-deen)
Brand Name: Examples include Actifed and Sudafed Sinus Nighttime

Pseudoephedrine/Triprolidine is used for:

Temporarily relieving symptoms of hay fever, allergies, or the common cold, including nasal congestion, runny nose, sneezing, itching of the nose and throat, and itchy/watery eyes. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Triprolidine is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Pseudoephedrine/Triprolidine if:

• you are allergic to any ingredient in Pseudoephedrine/Triprolidine
• you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days
• you have severe high blood pressure or severe heart disease (eg, coronary artery disease, ischemic heart disease)

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

Before using Pseudoephedrine/Triprolidine:

Some medical conditions may interact with Pseudoephedrine/Triprolidine. 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 glaucoma or increased pressure in the eyes; high blood pressure; diabetes; heart or blood vessel disease; overactive thyroid; seizures; blockage of the stomach, bowel, or bladder; trouble breathing when you sleep; trouble sleeping; a breathing problem (eg, asthma, emphysema, chronic bronchitis); the blood disease porphyria; or an enlarged prostate or prostate disease; or if you have difficulty urinating

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

• Furazolidone or MAO inhibitors (eg, phenelzine) because side effects such as severe headache, high blood pressure, or high fever may occur
• Bromocriptine or sodium oxybate (GHB) because the risk of side effects or toxic effects may be increased by Pseudoephedrine/Triprolidine
• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Triprolidine.
• Droxidopa because side effects such as irregular heartbeat or heart attack may occur
• Urinary alkalinizers (eg, sodium bicarbonate) because the side effects of Pseudoephedrine/Triprolidine may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Triprolidine 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/Triprolidine:

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

• Pseudoephedrine/Triprolidine may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of Pseudoephedrine/Triprolidine and are using 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/Triprolidine.

Important safety information:

• Pseudoephedrine/Triprolidine 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/Triprolidine. Using Pseudoephedrine/Triprolidine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Pseudoephedrine/Triprolidine. Pseudoephedrine/Triprolidine will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Contact your health care provider if symptoms last for more than 7 days or are accompanied by a fever.
• Diabetes patients – Pseudoephedrine/Triprolidine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Pseudoephedrine/Triprolidine contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, including medicine used on the skin, read the ingredients to see if it also contains pseudoephedrine. If it does, or if you are uncertain if it does, contact your doctor or pharmacist.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Triprolidine without checking with your doctor.
• Do not exceed the recommended dose or take Pseudoephedrine/Triprolidine for longer than prescribed without checking with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Pseudoephedrine/Triprolidine.
• Use Pseudoephedrine/Triprolidine with caution in the ELDERLY because they may be more sensitive to its effects.
• Pseudoephedrine/Triprolidine is not recommended for use in CHILDREN younger than 6 years of age without first checking with your doctor.
• Caution is advised when using Pseudoephedrine/Triprolidine in CHILDREN because they may be more sensitive to its effects, especially excitability.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant while taking Pseudoephedrine/Triprolidine, discuss with your doctor the benefits and risks of using Pseudoephedrine/Triprolidine during pregnancy. If you are or will be breast-feeding while you are using Pseudoephedrine/Triprolidine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pseudoephedrine/Triprolidine:

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 (especially in children); headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; vomiting.

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); blurred vision; chest pain; decreased coordination; difficulty urinating; fast or irregular heartbeat; fever; hallucinations; seizure; severe dizziness and drowsiness; severe nervousness, anxiety, or restlessness; tremors; unusual weakness.

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 bluish-colored skin; difficulty breathing; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; mental or mood changes; seizures; severe drowsiness or dizziness; severe excitability; severe nausea or vomiting; sweating; tremors.

Proper storage of Pseudoephedrine/Triprolidine:

Store Pseudoephedrine/Triprolidine at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Triprolidine out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Triprolidine, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Triprolidine 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/Triprolidine. 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/

Triprolidine Liquid

Generic Name: Pseudoephedrine/Triprolidine (soo-doe-e-FED-rin/try-PRO-li-deen)
Brand Name: Examples include Allerfrim and Zymine-D

Pseudoephedrine/Triprolidine Liquid is used for:

Temporarily relieving symptoms of hay fever, allergies, or the common cold, including nasal congestion, runny nose, sneezing, itching of the nose and throat, and itchy/watery eyes. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Triprolidine Liquid is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Pseudoephedrine/Triprolidine Liquid if:

• you are allergic to any ingredient in Pseudoephedrine/Triprolidine Liquid
• you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days
• you have severe high blood pressure or severe heart disease (eg, coronary artery disease, ischemic heart disease)

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

Before using Pseudoephedrine/Triprolidine Liquid:

Some medical conditions may interact with Pseudoephedrine/Triprolidine 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 glaucoma or increased pressure in the eyes; high blood pressure; diabetes; heart or blood vessel disease; overactive thyroid; seizures; blockage of the stomach, bowel, or bladder; trouble breathing when you sleep; trouble sleeping; a breathing problem (eg, asthma, emphysema, chronic bronchitis); the blood disease porphyria; or an enlarged prostate or prostate disease; or if you have difficulty urinating

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

• Furazolidone or MAO inhibitors (eg, phenelzine) because side effects such as severe headache, high blood pressure, or high fever may occur
• Bromocriptine or sodium oxybate (GHB) because the risk of side effects or toxic effects may be increased by Pseudoephedrine/Triprolidine Liquid
• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Triprolidine Liquid.
• Droxidopa because side effects such as irregular heartbeat or heart attack may occur
• Urinary alkalinizers (eg, sodium bicarbonate) because the side effects of Pseudoephedrine/Triprolidine Liquid may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Triprolidine 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/Triprolidine Liquid:

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

• Pseudoephedrine/Triprolidine Liquid may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• 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/Triprolidine Liquid and are using 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/Triprolidine Liquid.

Important safety information:

• Pseudoephedrine/Triprolidine Liquid 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/Triprolidine Liquid. Using Pseudoephedrine/Triprolidine Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Pseudoephedrine/Triprolidine Liquid. Pseudoephedrine/Triprolidine Liquid will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Contact your health care provider if symptoms last for more than 7 days or are accompanied by a fever.
• Diabetes patients – Pseudoephedrine/Triprolidine Liquid may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Pseudoephedrine/Triprolidine Liquid contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, including medicine used on the skin, read the ingredients to see if it also contains pseudoephedrine. If it does, or if you are uncertain if it does, contact your doctor or pharmacist.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Triprolidine Liquid without checking with your doctor.
• Do not exceed the recommended dose or take Pseudoephedrine/Triprolidine Liquid for longer than prescribed without checking with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Pseudoephedrine/Triprolidine Liquid.
• Use Pseudoephedrine/Triprolidine Liquid with caution in the ELDERLY because they may be more sensitive to its effects.
• Pseudoephedrine/Triprolidine Liquid is not recommended for use in CHILDREN younger than 6 years of age without first checking with your doctor.
• Caution is advised when using Pseudoephedrine/Triprolidine Liquid in CHILDREN because they may be more sensitive to its effects, especially excitability.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant while taking Pseudoephedrine/Triprolidine Liquid, discuss with your doctor the benefits and risks of using Pseudoephedrine/Triprolidine Liquid during pregnancy. If you are or will be breast-feeding while you are using Pseudoephedrine/Triprolidine Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pseudoephedrine/Triprolidine 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; dry mouth, nose, or throat; excitability (especially in children); headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; vomiting.

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); blurred vision; chest pain; decreased coordination; difficulty urinating; fast or irregular heartbeat; fever; hallucinations; seizure; severe dizziness and drowsiness; severe nervousness, anxiety, or restlessness; tremors; unusual weakness.

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 bluish-colored skin; difficulty breathing; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; mental or mood changes; seizures; severe drowsiness or dizziness; severe excitability; severe nausea or vomiting; sweating; tremors.

Proper storage of Pseudoephedrine/Triprolidine Liquid:

Store Pseudoephedrine/Triprolidine Liquid at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Triprolidine Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Triprolidine Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/Triprolidine 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/Triprolidine 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.

Generic Name: Pseudoephedrine (soo-doe-e-FED-rin)
Brand Name: Sudafed 12 Hour

Pseudoephedrine Sustained-Release Capsules are used for:

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

Pseudoephedrine Sustained-Release Capsules are a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Pseudoephedrine Sustained-Release Capsules if:

• you are allergic to any ingredient in Pseudoephedrine Sustained-Release Capsules
• you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days
• you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

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

Before using Pseudoephedrine Sustained-Release Capsules:

Some medical conditions may interact with Pseudoephedrine Sustained-Release Capsules. 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 heart problems, diabetes, glaucoma, an enlarged prostate or other prostate problems, adrenal gland problems, high blood pressure, seizures, stroke, blood vessel problems, or an overactive thyroid

Some MEDICINES MAY INTERACT with Pseudoephedrine Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rauwolfia derivatives (eg, reserpine) because the effectiveness of Pseudoephedrine Sustained-Release Capsules may be decreased
• Beta-blockers (eg, propranolol), cocaine, furazolidone, indomethacin, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Pseudoephedrine Sustained-Release Capsules may be increased
• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or droxidopa because the actions and side effects of these medicines may be increased
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because its effectiveness may be decreased by Pseudoephedrine Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine Sustained-Release Capsules 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 Sustained-Release Capsules:

Use Pseudoephedrine Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine Sustained-Release Capsules with food, water, or milk to minimize stomach irritation.
• Swallow Pseudoephedrine Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Pseudoephedrine Sustained-Release Capsules and 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 Sustained-Release Capsules.

Important safety information:

• Pseudoephedrine Sustained-Release Capsules may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pseudoephedrine Sustained-Release Capsules. Using Pseudoephedrine Sustained-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Pseudoephedrine Sustained-Release Capsules.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine Sustained-Release Capsules.
• Pseudoephedrine Sustained-Release Capsules 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.
• Diabetes patients – Pseudoephedrine Sustained-Release Capsules may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Use Pseudoephedrine Sustained-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Pseudoephedrine Sustained-Release Capsules with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Pseudoephedrine Sustained-Release Capsules during pregnancy. It is unknown if Pseudoephedrine Sustained-Release Capsules are excreted in breast milk. If you are or will be breast-feeding while you are using Pseudoephedrine Sustained-Release Capsules, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pseudoephedrine Sustained-Release Capsules:

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:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

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).

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 confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Pseudoephedrine Sustained-Release Capsules:

Store Pseudoephedrine Sustained-Release Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine Sustained-Release Capsules 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 Sustained-Release Capsules. 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.

Generic Name: Pseudoephedrine (soo-doe-e-FED-rin)
Brand Name: Sudafed 24 Hour

Pseudoephedrine Sustained-Release Tablets (24 Hour) are used for:

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

Pseudoephedrine Sustained-Release Tablets (24 Hour) are a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Pseudoephedrine Sustained-Release Tablets (24 Hour) if:

• you are allergic to any ingredient in Pseudoephedrine Sustained-Release Tablets (24 Hour)
• you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days
• you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

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

Before using Pseudoephedrine Sustained-Release Tablets (24 Hour):

Some medical conditions may interact with Pseudoephedrine Sustained-Release Tablets (24 Hour). 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 heart problems, diabetes, glaucoma, an enlarged prostate or other prostate problems, adrenal gland problems, high blood pressure, seizures, stroke, blood vessel problems, or an overactive thyroid

Some MEDICINES MAY INTERACT with Pseudoephedrine Sustained-Release Tablets (24 Hour). Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rauwolfia derivatives (eg, reserpine) because the effectiveness of Pseudoephedrine Sustained-Release Tablets (24 Hour) may be decreased
• Beta-blockers (eg, propranolol), cocaine, furazolidone, indomethacin, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Pseudoephedrine Sustained-Release Tablets (24 Hour) may be increased
• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or droxidopa because the actions and side effects of these medicines may be increased
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because its effectiveness may be decreased by Pseudoephedrine Sustained-Release Tablets (24 Hour)

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine Sustained-Release Tablets (24 Hour) 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 Sustained-Release Tablets (24 Hour):

Use Pseudoephedrine Sustained-Release Tablets (24 Hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine Sustained-Release Tablets (24 Hour) with food, water, or milk to minimize stomach irritation.
• Swallow Pseudoephedrine Sustained-Release Tablets (24 Hour) whole. Do not break, crush, or chew before swallowing.
• Do not take more than 1 tablet in 24 hours.
• If you miss a dose of Pseudoephedrine Sustained-Release Tablets (24 Hour) and 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 Sustained-Release Tablets (24 Hour).

Important safety information:

• Pseudoephedrine Sustained-Release Tablets (24 Hour) may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pseudoephedrine Sustained-Release Tablets (24 Hour). Using Pseudoephedrine Sustained-Release Tablets (24 Hour) alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Pseudoephedrine Sustained-Release Tablets (24 Hour).
• The tablet shell may not completely dissolve and may be seen in the stool. This is normal and not cause for concern.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine Sustained-Release Tablets (24 Hour).
• Pseudoephedrine Sustained-Release Tablets (24 Hour) 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.
• Diabetes patients – Pseudoephedrine Sustained-Release Tablets (24 Hour) may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Use Pseudoephedrine Sustained-Release Tablets (24 Hour) with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Pseudoephedrine Sustained-Release Tablets (24 Hour) with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Pseudoephedrine Sustained-Release Tablets (24 Hour) during pregnancy. It is unknown if Pseudoephedrine Sustained-Release Tablets (24 Hour) are excreted in breast milk. If you are or will be breast-feeding while you are using Pseudoephedrine Sustained-Release Tablets (24 Hour), check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pseudoephedrine Sustained-Release Tablets (24 Hour):

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:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

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).

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 confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Pseudoephedrine Sustained-Release Tablets (24 Hour):

Store Pseudoephedrine Sustained-Release Tablets (24 Hour) at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine Sustained-Release Tablets (24 Hour) out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine Sustained-Release Tablets (24 Hour), please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine Sustained-Release Tablets (24 Hour) 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 Sustained-Release Tablets (24 Hour). 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.

Generic Name: Pseudoephedrine (soo-doe-e-FED-rin)
Brand Name: Examples include Children’s Sudafed and Unifed

Pseudoephedrine Liquid is used for:

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

Pseudoephedrine Liquid is a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Pseudoephedrine Liquid if:

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

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

Before using Pseudoephedrine Liquid:

Some medical conditions may interact with Pseudoephedrine 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 a history of heart problems, diabetes, glaucoma, an enlarged prostate or other prostate problems, adrenal gland problems, high blood pressure, seizures, stroke, blood vessel problems, or an overactive thyroid

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

• Rauwolfia derivatives (eg, reserpine) because the effectiveness of Pseudoephedrine Liquid may be decreased
• Beta-blockers (eg, propranolol), cocaine, furazolidone, indomethacin, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Pseudoephedrine Liquid may be increased
• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or droxidopa because the actions and side effects of these medicines may be increased
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because its effectiveness may be decreased by Pseudoephedrine Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine 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 Liquid:

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

• Take Pseudoephedrine Liquid with food, water, or milk to minimize stomach irritation.
• 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 Liquid and 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 Liquid.

Important safety information:

• Pseudoephedrine Liquid may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pseudoephedrine Liquid. Using Pseudoephedrine Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Pseudoephedrine Liquid.
• Do not take diet or appetite control medicines while you are taking Pseudoephedrine Liquid.
• Pseudoephedrine Liquid 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.
• Diabetes patients – Pseudoephedrine Liquid may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Use Pseudoephedrine Liquid with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Pseudoephedrine Liquid with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Pseudoephedrine Liquid during pregnancy. It is unknown if Pseudoephedrine Liquid is excreted in breast milk. If you are or will be breast-feeding while you are using Pseudoephedrine Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pseudoephedrine 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:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

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).

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 confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Pseudoephedrine Liquid:

Store Pseudoephedrine Liquid at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine 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 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.