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acetaminophen, chlorpheniramine, and codeine

Generic Name: acetaminophen, chlorpheniramine, and codeine (a seet a MIN oh fen, klor fen IR a meen, KOE deen)
Brand Name: Cotabflu

What is acetaminophen, chlorpheniramine, and codeine?

Acetaminophen is a pain reliever and fever reducer.

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

Codeine is a narcotic cough suppressant.

Acetaminophen, chlorpheniramine, and codeine is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu. This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, chlorpheniramine, and codeine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

You should not use this medicine if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use acetaminophen, chlorpheniramine, and codeine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you are allergic to acetaminophen, chlorpheniramine, or codeine, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use acetaminophen, chlorpheniramine, and codeine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

To make sure this medicine is safe for you, tell your doctor if you have:

  • liver disease, cirrhosis, or if you drink more than 3 alcoholic beverages per day;

  • a history of alcoholism or drug addiction;

  • a blockage in your stomach or intestines;

  • diarrhea, inflammatory bowel disease;

  • a colostomy or ileostomy;

  • glaucoma;

  • kidney disease;

  • bladder obstruction or other urination problems;

  • asthma, COPD, sleep apnea, or other breathing disorders;

  • a history of head injury, brain tumor, or stroke;

  • if you are dehydrated; or

  • if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

Codeine may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. Codeine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Do not use this medicine without telling your doctor if you are pregnant.

Codeine can pass into breast milk. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not breast-feed while taking acetaminophen, chlorpheniramine, and codeine.

How should I take this medicine?

Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen or codeine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may include confusion, extreme weakness, pinpoint pupils, cold and clammy skin, weak pulse, slow breathing, fainting, or breathing that stops.

What should I avoid while taking this medicine?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Do not drink alcohol while you are taking this medicine. Dangerous side effects or death can occur when alcohol is combined with a narcotic medicine. Alcohol may also increase your risk of liver damage while you are taking acetaminophen.

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

This medicine 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.

Seek emergency medical attention if a child taking this medication has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

  • fast, slow, or uneven heart rate;

  • confusion, mood changes, severe dizziness or anxiety, seizure;

  • sudden severe headache or vomiting;

  • pain or numbness in the arms or legs;

  • fever, easy bruising or bleeding, unusual weakness;

  • little or no urinating;

  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Common side effects may include:

  • drowsiness, mild headache, blurred vision;

  • dry mouth, nose, or throat;

  • upset stomach, constipation;

  • feeling restless or nervous; or

  • sleep problems (insomnia).

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.

See also: Side effects (in more detail)

Acetaminophen, chlorpheniramine, and codeine dosing information

Usual Adult Dose for Allergic Rhinitis:

Acetaminophen/chlorpheniramine/codeine 500 mg-4 mg-20 mg oral tablet:
1 tablet orally every 4 to 6 hours not to exceed 6 tablets daily.

Usual Adult Dose for Cough and Nasal Congestion:

Acetaminophen/chlorpheniramine/codeine 500 mg-4 mg-20 mg oral tablet:
1 tablet orally every 4 to 6 hours not to exceed 6 tablets daily.

Usual Pediatric Dose for Allergic Rhinitis:

Acetaminophen/chlorpheniramine/codeine 500 mg-4 mg-20 mg oral tablet:
6 to 11 years: 0.5 tablet orally every 4 to 6 hours not to exceed 3 tablets daily.
12 years or older: 1 tablet orally every 4 to 6 hours not to exceed 6 tablets daily.

Usual Pediatric Dose for Cough and Nasal Congestion:

Acetaminophen/chlorpheniramine/codeine 500 mg-4 mg-20 mg oral tablet:
6 to 11 years: 0.5 tablet orally every 4 to 6 hours not to exceed 3 tablets daily.
12 years or older: 1 tablet orally every 4 to 6 hours not to exceed 6 tablets daily.

What other drugs will affect this medicine?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking acetaminophen, chlorpheniramine, and codeine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with acetaminophen, chlorpheniramine, and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about acetaminophen, chlorpheniramine, and codeine.
  • 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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision Date: 2013-11-01, 4:32:25 PM.

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