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Medications and Drugs

Brand Names: Cold & Cough PE, Cold Head Congestion Severe Daytime, Cold Multi-Symptom Severe Daytime Cool Ice, Mucinex Children's Cold, Cough & Sore Throat, Mucinex Children's Multi-Symptom Cold & Fever, Mucinex Fast-Max Cold, Flu & Sore Throat, Mucinex Fast-Max Severe Congestion & Cold, Non-Pseudo Cold Relief, Phenflu DM, Sudafed PE Cold & Cough, Tylenol Cold & Flu Severe, Tylenol Cold Head Congestion Severe, Tylenol Cold Multi-Symptom Severe, Tylenol Cold Multi-Symptom Severe Daytime

Generic Name: acetaminophen, dextromethorphan, guaifenesin, and phenylephrine (Pronunciation: a SEET oh MIN oh fen, DEX troe me THOR fan, gwye FEN e sin, FEN il EFF rin)

What is acetaminophen, dextromethorphan, guaifenesin, and phenylephrine (Cold & Cough PE, Cold Head Congestion Severe Daytime, Cold Multi-Symptom Severe Daytime Cool Ice, Mucinex Children's Cold, Cough & Sore Throat, Mucinex Children's Multi-Symptom Cold & Fever, Mucinex Fast-Max Cold, Flu & Sore Throat, Mucinex Fast-Max Severe Congestion & Cold, Non-Pseudo Cold Relief, Phenflu DM, Sudafed PE Cold & Cough, Tylenol Cold & Flu Severe, Tylenol Cold Head Congestion Severe, Tylenol Cold Multi-Symptom Severe, Tylenol Cold Multi-Symptom Severe Daytime)?

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.

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

Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine is a combination medicine 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 phenylephrine 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; difficult breathing; swelling of your face, lips, tongue, or throat.

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

  • 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).

Common 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 taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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

Need help identifying pills and medications?
Use the pill finder tool on RxList.



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