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Medications and Drugs

Brand Names: Duraflu, Maxiflu DM, Robitussin Cold Cough and Flu, Theraflu Chest and Cough, Theraflu Max-D Severe Cold & Flu, 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, Theraflu Max-D Severe Cold & Flu, 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 headache, fever, body aches, cough, chest congestion, stuffy nose, and sinus congestion 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, dextromethorphan, guaifenesin, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What are the possible side effects of this medicine?

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:

  • chest pain, fast, slow, or uneven heart rate;
  • severe dizziness, feeling like you might pass out;
  • mood changes, confusion, hallucinations;
  • tremor, seizure (convulsions);
  • fever;
  • urinating less than usual or not at all;
  • 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).

Less serious side effects may include:

  • dizziness, weakness;
  • mild headache;
  • mild nausea, diarrhea, upset stomach;
  • dry mouth, nose, or throat;
  • feeling nervous, restless, irritable, or anxious; 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.

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

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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.



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.

Pill Identifier Tool

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Use the pill finder tool on RxList.



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