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Medications and Drugs

Brand Names: Duraflu, Maxiflu DM, Robitussin Cold Cough and Flu, Theraflu Chest and Cough, Tylenol Cold Severe Congestion Non-Drowsy

Generic Name: acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine (Pronunciation: a SEET a MIN oh fen, DEX troe me THOR fan, gwye FEN e sin, SOO doe ee FED rin)

What is acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine (Duraflu, Maxiflu DM, Robitussin Cold Cough and Flu, Theraflu Chest and Cough, Tylenol Cold Severe Congestion Non-Drowsy)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

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

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

The combination of acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine is used to treat stuffy nose, sinus congestion, cough, chest congestion, and pain or fever caused by the common cold or flu.

Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine (Duraflu, Maxiflu DM, Robitussin Cold Cough and Flu, Theraflu Chest and Cough, Tylenol Cold Severe Congestion Non-Drowsy)?

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;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • confusion, hallucinations;
  • slow, shallow breathing;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild loss of appetite, upset stomach;
  • warmth, tingling, or redness under your skin;
  • feeling excited or restless;
  • sleep problems (insomnia); or
  • skin rash or itching.

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 is the most important information I should know about acetaminophen, dextromethorphan, guaifenesin, and pseudoephedrine (Duraflu, Maxiflu DM, Robitussin Cold Cough and Flu, Theraflu Chest and Cough, Tylenol Cold Severe Congestion Non-Drowsy)?

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 use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) within the past 14 days.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP), dextromethorphan, guaifenesin, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains acetaminophen or APAP, dextromethorphan, guaifenesin, or pseudoephedrine.

Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day.



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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