Generic Name: carbinoxamine, hydrocodone, and phenylephrine (kar bi NOX a meen, hy dro KOE done, fen il EFF rin)
Brand Names: Donatussin MAX, Excof, Excof-SF

What is Excof-SF (carbinoxamine, hydrocodone, and phenylephrine)?

Carbinoxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is a narcotic cough suppressant. It suppresses an area in the brain that causes coughing.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Carbinoxamine, hydrocodone, and phenylephrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

This medication may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Excof-SF (carbinoxamine, hydrocodone, and phenylephrine)?

Always ask a doctor before giving a cough or cold medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children. Do not use carbinoxamine, hydrocodone, and phenylephrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. Carbinoxamine, hydrocodone, and phenylephrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Do not take this product for cough caused by smoking, asthma, or emphysema. Do not take this medicine if your cough produces a lot of mucus, unless your doctor has told you to.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my health care provider before taking Excof-SF (carbinoxamine, hydrocodone, and phenylephrine)?

Do not give this medication to a child younger than 2 years old, even if the medicine label provides dosing intructions for children in this age group. Deaths have been reported in children under 2 years old who had received carbinoxamine, although it has not been determined that carbinoxamine was the cause of these deaths. Talk with your doctor about other FDA-approved products available for use in young children with cold or allergy symptoms. Do not use carbinoxamine, hydrocodone, and phenylephrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to carbinoxamine, hydrocodone, or phenylephrine, or if you have:

• a history of drug or alcohol addiction;

• kidney disease;
• liver disease;

• diabetes;

• glaucoma;

• heart disease or high blood pressure;

• coronary artery disease;

• a stomach ulcer or an obstruction in your stomach or intestines;

• an enlarged prostate or urination problems;

• head injury, brain injury, or brain tumor;

• Addison’s disease;

• thyroid problems;

• emphysema or chronic bronchitis;

• asthma.

If you have any of these conditions, you may not be able to take this medication, or you may require a dosage adjustment or special monitoring during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Carbinoxamine, hydrocodone, and phenylephrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

How should I take Excof-SF (carbinoxamine, hydrocodone, and phenylephrine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

You may take this medication with or without food.

If the medication upsets your stomach, you may take it with food or milk.

Measure the liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Hydrocodone may cause constipation. Drink 6 to 8 full glasses of water each day while you are taking this medicine. Increasing the amount of fiber in your diet may also help relieve constipation.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medicine.

Symptoms of an overdose may include dizziness, ringing in the ears, blurred vision, large pupils, dry mouth, a weak heartbeat, extreme drowsiness, sweating, shaking, pale skin, blue lips and fingernails, hallucinations, confusion, seizures, shallow breathing, coma, and death.

What should I avoid while taking Excof-SF (carbinoxamine, hydrocodone, and phenylephrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines, decongestants, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

Avoid using other medicines that make you sleepy (such as cold medicine, other narcotics, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by carbinoxamine, hydrocodone, and phenylephrine.

Excof-SF (carbinoxamine, hydrocodone, and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• seizure (convulsions);

• unusual behavior or hallucinations;

• an irregular or fast heartbeat;

• feeling light-headed, fainting;

• urinating less than usual or not at all;

• wheezing, tightness in your chest;

• fast or pounding heartbeat;

• jaundice (yellowing of the skin or eyes);

• pale skin, easy bruising or bleeding;

• slow or weak breathing; or

• swelling, rapid weight gain.

Continue taking this medication and talk to your doctor if you have any of these less serious side effects:

• drowsiness, dizziness;

• lack of coordination;

• upset stomach, nausea, stomach cramps, or constipation;

• stuffy nose, chest congestion;

• sleep problems (insomnia);

• itchy skin rash;

• decreased hearing or ringing in the ears;

• feeling restless or excited (especially in children);

• dry mouth or nose; or

• blurred vision.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

The hydrocodone in this medication may cause constipation. Drink plenty of water (six to eight full glasses a day) to lessen this side effect. Increasing the amount of fiber in your diet may also help to alleviate constipation.

What other drugs will affect Excof-SF (carbinoxamine, hydrocodone, and phenylephrine)?

Do not take this medication if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), or selegiline (Eldepryl) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking carbinoxamine, hydrocodone, and phenylephrine, tell your doctor if you are taking any of the following medicines:

• medicine to treat high blood pressure or a heart condition;

• medicine to treat diabetes;

• weight loss medication;

• another decongestant (cold or allergy product); or

• antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

If you are using any of these drugs, you may not be able to use carbinoxamine, hydrocodone, and phenylephrine or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect carbinoxamine, hydrocodone, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has additional information about carbinoxamine, hydrocodone, and phenylephrine written for health professionals that you may read.

What does my medication look like?

Carbinoxamine, hydrocodone, and phenylephrine is available with a prescription under the brand names Donatussin and Excof. Other brand and generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 04/14/2007 10:28:12 AM.

Generic Name: Carbinoxamine/Hydrocodone/Phenylephrine (car-bihn-OCKS-ah-meen/hye-droe-KOE-done/fen-il-EF-rin)
Brand Name: Examples include Excof-SF and Max HC

Excof-SF Liquid is used for:

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

Excof-SF Liquid is a decongestant, antihistamine, and narcotic 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, which reduces a dry cough.

Do NOT use Excof-SF Liquid if:

• you are allergic to any ingredient in Excof-SF Liquid or any other codeine- or morphine-related medicine (eg, oxycodone)
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you are unable to urinate or are having an asthma attack
• you have diarrhea due to antibiotic use or poisoning
• you are taking sodium oxybate (GHB), droxidopa, or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Excof-SF Liquid:

Some medical conditions may interact with Excof-SF 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 or other heart or blood vessel problems
• if you have a history of adrenal gland problems (eg, adrenal gland tumor); liver or kidney problems; high blood pressure; diabetes; stroke; glaucoma; increased pressure in the eye; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; trouble sleeping; an enlarged prostate or other prostate problems; or thyroid problems
• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus
• if you have a history of head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures
• if you have a history of stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel, chronic constipation), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery
• if you are very ill or very weak or you have a history of alcohol or substance abuse or suicidal thoughts or behavior

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Excof-SF Liquid’s side effects
• Barbiturates (eg, phenobarbital), cimetidine, digoxin, droxidopa, or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased
• Naltrexone because it may decrease Excof-SF Liquid’s effectiveness
• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Excof-SF Liquid
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Excof-SF Liquid

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

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

• Take Excof-SF Liquid by mouth with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Excof-SF Liquid and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Excof-SF Liquid.

Important safety information:

• Excof-SF Liquid may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Excof-SF 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 Excof-SF Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do not use Excof-SF Liquid for a cough with a lot of mucous. 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 diet or appetite control medicines while you are taking Excof-SF Liquid without checking with your doctor.
• Excof-SF Liquid has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.
• Excof-SF Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Excof-SF Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Excof-SF 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 Excof-SF Liquid for a few days before the tests.
• Tell your doctor or dentist that you take Excof-SF Liquid before you receive any medical or dental care, emergency care, or surgery.
• Use Excof-SF Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness or excitability.
• Caution is advised when using Excof-SF Liquid in CHILDREN; they may be more sensitive to its effects, especially drowsiness or excitability.
• Excof-SF Liquid should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Excof-SF Liquid may cause harm to the fetus if taken during late pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Excof-SF Liquid while you are pregnant. It is not known if Excof-SF Liquid is found in breast milk. Do not breast-feed while taking Excof-SF Liquid.

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

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

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

Possible side effects of Excof-SF 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; excitability; headache; loss of appetite; nausea; nervousness or anxiety; restlessness; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; vision changes.

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 cold, clammy skin; confusion; difficulty breathing; dilated pupils; flushing; hallucinations; loss of coordination; overexcitement; seizures; severe dizziness, lightheadedness, headache, or vomiting; severe drowsiness; unusually fast, slow, or irregular heartbeat.

Proper storage of Excof-SF Liquid:

Store Excof-SF 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 Excof-SF Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Excof-SF Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Excof-SF 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 Excof-SF 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: guaifenesin and hydrocodone (gwye FEN e sin and HYE droe KOE done)
Brand Names: A-Cof DH, Canges-XP, Codiclear DH, Condasin, Cotuss V, Execlear, Extendryl HC, Hycotuss Expectorant, Hydrocod-GF, Kwelcof, Monte-G HC, Narcof, Pancof XP, Pneumotussin 2.5, Relasin-HCX, Touro HC, Tussicle, Tusso-DF, Vi-Q-Tuss, Vitussin Expectorant, Xpect-HC, Z-Cof HCX

What is Execlear (guaifenesin and hydrocodone)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Hydrocodone is a narcotic cough suppressant.

Guaifenesin and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.

Guaifenesin and hydrocodone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Execlear (guaifenesin and hydrocodone)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It may increase drowsiness and dizziness caused by guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking Execlear (guaifenesin and hydrocodone)?

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not use this medicine if you are allergic to hydrocodone or guaifenesin.

Before taking this medication, tell your doctor if you have:

• kidney disease;
• liver disease;

• asthma;

• urination problems;

• an enlarged prostate;

• a thyroid disorder;

• seizures or epilepsy;

• gallbladder disease;

• a head injury; or

• Addison’s disease.

If you have any of these conditions, you may not be able to take guaifenesin and hydrocodone, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Guaifenesin and hydrocodone passes into breast milk and may be harmful to a nursing baby. Do not take guaifenesin and hydrocodone without telling your doctor if you are breast-feeding a baby.

How should I take Execlear (guaifenesin and hydrocodone)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Guaifenesin and hydrocodone can be taken with or without food.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take more of this medication or take it for longer than is recommended. Call your doctor if your symptoms do not improve, or if they get worse. Store guaifenesin and hydrocodone at room temperature away from moisture and heat. Keep track of how many pills have been used from each new bottle of this medicine. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dry mouth, confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, seizure (convulsions), weak or shallow breathing, or breathing that stops.

What should I avoid while taking Execlear (guaifenesin and hydrocodone)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It may increase drowsiness and dizziness caused by guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone.

Do not take other over-the-counter cough, cold, allergy, pain, or sleep medications without first asking your doctor or pharmacist. Guaifenesin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much guaifenesin. Read the label of any other medicine you are using to see if it contains guaifenesin.

Execlear (guaifenesin and hydrocodone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• slow heart rate, weak or shallow breathing;

• feeling like you might pass out;

• confusion, fear, unusual thoughts or behavior;

• seizure (convulsions); or

• urinating less than usual or not at all.

Less serious side effects may include:

• dizziness, drowsiness;

• nausea, vomiting, upset stomach;

• blurred vision;

• constipation;

• dry mouth; or

• sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Execlear (guaifenesin and hydrocodone)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• antidepressants such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

• a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with guaifenesin and hydrocodone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and hydrocodone.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 4/12/2009 4:41:00 PM.

Generic Name: acetaminophen and aspirin (a seet oh MIN oh fen and AS prin)
Brand Names: Excedrin Back & Body

What is Excedrin Back & Body (acetaminophen and aspirin)?

Acetaminophen is a pain reliever and fever reducer.

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

The combination of acetaminophen and aspirin is used to treat minor arthritis pain, back pain, and muscle aches.

Acetaminophen and aspirin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Excedrin Back & Body (acetaminophen and aspirin)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other pain, headache, cold, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) and aspirin are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, or aspirin. This medicine should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye’s syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol. It can increase the risk of stomach bleeding or liver damage while you are taking acetaminophen and aspirin. If you drink more than 3 alcoholic beverages per day, do not take acetaminophen without your doctor’s advice.

What should I discuss with my health care provider before taking Excedrin Back & Body (acetaminophen and aspirin)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or aspirin, or if you are using any other products that contain acetaminophen. This medicine should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye’s syndrome in children.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Ask a doctor or pharmacist about using acetaminophen and aspirin if you have:

• asthma;

• a recent history of stomach or intestinal bleeding;

• stomach ulcer or history of heartburn or ongoing indigestion or stomach pain;

• a bleeding or blood clotting disorder; or

• liver disease (including cirrhosis).

Do not use this medication without telling your doctor if you are pregnant. Aspirin can cause harm to an unborn baby or problems with childbirth if you take the medicine during the last 3 months of pregnancy. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Acetaminophen and aspirin may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 12 years old without the advice of a doctor.

How should I take Excedrin Back & Body (acetaminophen and aspirin)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended. An overdose of acetaminophen and aspirin can cause serious harm.

Take this medication with a full glass of water.

Do not take more than 8 tablets in 24 hours unless your doctor has told you to.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.

Store acetaminophen and aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since acetaminophen and aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of this medication can cause serious harm.

Overdose can cause ringing in your ears, dizziness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, yellowing of your skin or eyes, increased sweating, confusion, hallucinations, rapid breathing, seizure (convulsions), or coma.

What should I avoid while taking Excedrin Back & Body (acetaminophen and aspirin)?

Avoid drinking alcohol. It can increase the risk of stomach bleeding or liver damage while you are taking acetaminophen and aspirin. If you drink more than 3 alcoholic beverages per day, do not take acetaminophen without your doctor’s advice. Do not use any other pain, headache, cold, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) and aspirin are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, or aspirin.

Excedrin Back & Body (acetaminophen and aspirin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever lasting longer than 3 days;

• swelling, or pain lasting longer than 10 days;

• redness, swelling, or other signs of infection; or

• hearing loss.

Less serious side effects may include:

• upset stomach, heartburn;

• drowsiness; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Excedrin Back & Body (acetaminophen and aspirin)?

Before taking aspirin, tell your doctor if you are using any of the following drugs:

• a blood thinner such as warfarin (Coumadin);

• medications for treating diabetes;

• gout medications such as probenecid (Benemid);

• another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan’s, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid); or

• an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen and aspirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has information about acetaminophen and aspirin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 11/17/2009 11:26:57 AM.

Generic Name: Acetaminophen and Aspirin (a-SEET-a-MIN-oh-fen/AS-pir-in)
Brand Name: Excedrin Back & Body Extra Strength

Excedrin Back & Body Extra Strength is used for:

Treating minor aches and pains (eg, due to headache, muscle aches, backache, arthritis, the common cold, flu, toothache, menstrual cramps) and temporarily reducing fever. It may also be used for other conditions as determined by your doctor.

Excedrin Back & Body Extra Strength is an analgesic and antipyretic combination. It works in the brain to help relieve pain and reduce fever. Aspirin also helps to reduce inflammation.

Do NOT use Excedrin Back & Body Extra Strength if:

• you are allergic to any ingredient in Excedrin Back & Body Extra Strength
• you are a child or teenager who has recently had an influenza vaccine (eg, flu shot)
• you are a child or teenager who has or has recently had a flu-like illness (eg, fever, chills, sore throat), chickenpox, or any other type of viral infection
• you have bleeding problems such as hemophilia, von Willebrand disease, low blood platelets, or active severe bleeding
• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, celecoxib, ibuprofen, naproxen)
• you are taking other medicines that contain acetaminophen

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

Before using Excedrin Back & Body Extra Strength:

Some medical conditions may interact with Excedrin Back & Body Extra Strength. 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 alcohol abuse or if you drink 3 or more alcohol-containing drinks every day
• if you have recently had an influenza vaccine (eg, flu shot)
• if you have or have recently had a flu-like illness (eg, fever, chills, sore throat), chickenpox, or any other type of viral infection
• if you have a history of asthma, growths in the nose (nasal polyps), diabetes, gout, kidney problems, liver problems (eg, hepatitis), persistent or frequent stomach problems (eg, heartburn, upset stomach, stomach pain), peptic ulcers, or bleeding ulcers
• if you have bleeding or clotting problems, vitamin K deficiency, a weakened blood vessel in the brain (eg, cerebral aneurysm), or a history of stroke or bleeding in the brain
• if you are a child with Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with Excedrin Back & Body Extra Strength. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Isoniazid because the risk of liver problems may be increased
• Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease Excedrin Back & Body Extra Strength’s effectiveness
• Anticoagulants (eg, heparin, warfarin), clopidogrel, NSAIDs (eg, ibuprofen, celecoxib, ketorolac), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of their side effects, including risk of bleeding, may be increased by Excedrin Back & Body Extra Strength
• Insulin and oral antidiabetics (eg, glyburide, nateglinide) because the risk of their side effects, including low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating), may be increased by Excedrin Back & Body Extra Strength
• Methotrexate or valproic acid because their actions and the risk of their side effects may be increased by Excedrin Back & Body Extra Strength
• Probenecid or sulfinpyrazone because their effectiveness may be decreased by Excedrin Back & Body Extra Strength

This may not be a complete list of all interactions that may occur. Ask your health care provider if Excedrin Back & Body Extra Strength 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 Excedrin Back & Body Extra Strength:

Use Excedrin Back & Body Extra Strength as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Excedrin Back & Body Extra Strength by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not decrease the risk of stomach or bowel problems (eg, bleeding, ulcers) that may occur while taking Excedrin Back & Body Extra Strength.
• Take Excedrin Back & Body Extra Strength with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Excedrin Back & Body Extra Strength.
• If Excedrin Back & Body Extra Strength has a strong vinegar-like smell upon opening, do not use it. The medicine may be breaking down. Throw the bottle away safely and out of the reach of children and pets; contact your pharmacist and replace.
• If you miss a dose of Excedrin Back & Body Extra Strength, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Excedrin Back & Body Extra Strength.

Important safety information:

• Excedrin Back & Body Extra Strength has aspirin and acetaminophen in it. Before you start any new medicine, check the label to see if it has aspirin or acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Serious stomach ulcers or bleeding can occur with the use of Excedrin Back & Body Extra Strength. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Excedrin Back & Body Extra Strength 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.
• Excedrin Back & Body Extra Strength may harm your liver. Your risk may be greater if you drink alcohol while you are using Excedrin Back & Body Extra Strength. Talk to your doctor before you take Excedrin Back & Body Extra Strength or other pain relievers or fever reducers if you drink more than 3 drinks with alcohol per day.
• Do NOT take more than the recommended dose. Do not take Excedrin Back & Body Extra Strength for more than 10 days for pain or for more than 3 days for fever without checking with your doctor. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor right away.
• Excedrin Back & Body Extra Strength may reduce the action of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Aspirin has been linked to a serious illness called Reye syndrome. Do not give Excedrin Back & Body Extra Strength to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
• Tell your doctor or dentist that you take Excedrin Back & Body Extra Strength before you receive any medical or dental care, emergency care, or surgery.
• Do not take Excedrin Back & Body Extra Strength for at least 7 days after any surgery unless directed by your health care provider.
• Excedrin Back & Body Extra Strength may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Excedrin Back & Body Extra Strength and need to check your blood cholesterol at home.
• Use Excedrin Back & Body Extra Strength with caution in the ELDERLY; they may be more sensitive to its effects.
• Different brands of Excedrin Back & Body Extra Strength may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
• Check with your child’s doctor before giving Excedrin Back & Body Extra Strength to a CHILD younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Excedrin Back & Body Extra Strength while you are pregnant. Excedrin Back & Body Extra Strength is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Excedrin Back & Body Extra Strength is found in breast milk. If you are or will be breast-feeding while you use Excedrin Back & Body Extra Strength, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Excedrin Back & Body Extra Strength:

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:

Heartburn; nausea; upset stomach.

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); black or bloody stools; confusion; dark urine or pale stools; diarrhea; dizziness; drowsiness; hearing loss; ringing in the ears; severe stomach pain; unusual fatigue; vomiting; yellowing of the 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 agitation; dark urine or pale stools; excessive sweating; extreme fatigue; fast breathing; fast or irregular heartbeat; fever; hearing loss; lethargy; lightheadedness, especially upon standing; nausea; ringing in the ears; seizures; shortness of breath; stomach pain; vomiting; yellowing of the skin or eyes.

Proper storage of Excedrin Back & Body Extra Strength:

Store Excedrin Back & Body Extra Strength 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 Excedrin Back & Body Extra Strength out of the reach of children and away from pets.

General information:

• If you have any questions about Excedrin Back & Body Extra Strength, please talk with your doctor, pharmacist, or other health care provider.
• Excedrin Back & Body Extra Strength 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 Excedrin Back & Body Extra Strength. 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.