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Medications and Drugs

Brand Names: Cotabflu

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

What is acetaminophen, chlorpheniramine, and codeine (Cotabflu)?

Acetaminophen is a pain reliever and fever reducer.

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

Codeine is a narcotic cough suppressant.

The combination of acetaminophen, chlorpheniramine, and codeine is used to treat runny nose, cough, and pain or fever caused by allergies or the common cold.

Codeine will not treat a cough that is caused by smoking, asthma, or emphysema.

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

What are the possible side effects of acetaminophen, chlorpheniramine, and codeine (Cotabflu)?

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:

  • severe weakness, dizziness, anxiety, restless feeling, or nervousness;
  • confusion, hallucinations, unusual thoughts or behavior;
  • seizure (convulsions);
  • chest pain or tightness;
  • fast, pounding, or uneven heartbeats;
  • slow heart rate, weak pulse, fainting, weak or shallow breathing;
  • signs of infection such as fever, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums);
  • urinating less than usual or not at all; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dry eyes, blurred vision;
  • dry mouth, upset stomach, constipation;
  • warmth, tingling, or redness under your skin;
  • dizziness, drowsiness;
  • restless or excitability (especially in children);
  • constipation;
  • headache;
  • increased sweating; or
  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about acetaminophen, chlorpheniramine, and codeine (Cotabflu)?

Do not take this medication 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 a cough and cold medicine before the MAO inhibitor has cleared from your body.

Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. If you drink more than three alcoholic beverages per day, do not take this medication without your doctor's advice, and never take more than 2 grams (2000 mg) of acetaminophen per day.

Do not use any other cough, cold, or allergy medication without first asking your doctor or pharmacist. 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 (sometimes abbreviate as "APAP") or chlorpheniramine.

Do not give this medicine to a child without a doctor's advice. Death can occur from the misuse of cough or cold medicine in very young children. Always ask your doctor before treating a cough or cold in a child.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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