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Medications and Drugs

Brand Names: Robitussin Night Relief

Generic Name: acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine (Pronunciation: a SEET a MIN oh fen, pir IL a meen, DEX troe meth OR fan, SOO doe e FED rin)

What is acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine (Robitussin Night Relief)?

Acetaminophen is a pain reliever and fever reducer.

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

Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.

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, pseudoephedrine, and pyrilamine is used to treat runny or stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

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

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

What are the possible side effects of acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine (Robitussin Night Relief)?

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, unusual thoughts or behavior;
  • 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, pseudoephedrine, and pyrilamine (Robitussin Night Relief)?

Do not take 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) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP), dextromethorphan, pseudoephedrine, and pyrilamine 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, APAP, or a decongestant, antihistamine, or cough suppressant.

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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