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Medications and Drugs

Brand Names: Flu & Severe Cold Night Time, Theraflu Cold & Sore Throat, Theraflu Flu & Sore Throat, Theraflu Nighttime Severe Cold, Theraflu Sinus & Cold

Generic Name: acetaminophen, pheniramine, and phenylephrine (Pronunciation: a SEET a MIN o fen, fen EER a meen, FEN il EFF rin)

What is acetaminophen, pheniramine, and phenylephrine (Flu & Severe Cold Night Time, Theraflu Cold & Sore Throat, Theraflu Flu & Sore Throat, Theraflu Nighttime Severe Cold, Theraflu Sinus & Cold)?

Acetaminophen is a pain reliever and a fever reducer.

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

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

Acetaminophen, pheniramine, and phenylephrine is a combination medicine used to treat headache, runny nose, sneezing, stuffy nose, sinus congestion, watery eyes, and pain or fever caused by allergies, the common cold, or the flu.

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

What are the possible side effects of acetaminophen, pheniramine, and phenylephrine (Flu & Severe Cold Night Time, Theraflu Cold & Sore Throat, Theraflu Flu & Sore Throat, Theraflu Nighttime Severe Cold, Theraflu Sinus & Cold)?

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 the medicine and call your doctor at once if you have:

  • chest pain, rapid pulse, fast or uneven heart rate;
  • confusion, hallucinations, tremor, severe dizziness or anxiety;
  • slow, shallow breathing;
  • little or no urinating;
  • easy bruising or bleeding, unusual weakness;
  • nausea, pain in your upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects may include:

  • dryness of the eyes, nose, and mouth;
  • blurred vision;
  • dizziness, drowsiness, problems with memory or concentration;
  • ringing in your ears;
  • feeling restless or irritable; or
  • mild nausea, stomach pain, constipation.

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, pheniramine, and phenylephrine (Flu & Severe Cold Night Time, Theraflu Cold & Sore Throat, Theraflu Flu & Sore Throat, Theraflu Nighttime Severe Cold, Theraflu Sinus & Cold)?

Ask a doctor before taking medicine that contains acetaminophen if you have ever had liver disease, or if you drink more than 3 alcoholic beverages per day.

Do not use cold or allergy 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.

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

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.

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

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.



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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