Medications and Drugs
Brand Names: Benadryl Allergy & Cold, Benadryl Allergy & Sinus Headache, Robitussin Nighttime Multi-Symptom Cold, Sudafed PE Severe Cold, Theraflu Severe Cold & Cough Nighttime, Theraflu Warming Flu & Sore Throat, Theraflu Warming Severe Cold Nighttime, Theraflu Warming Sinus & Cold
Generic Name: acetaminophen, diphenhydramine, and phenylephrine (Pronunciation: a SEET a MIN oh fen, DYE fen HYE dra meen, and FEN il EFF rin)
What is acetaminophen, diphenhydramine, and phenylephrine (Benadryl Allergy & Cold, Benadryl Allergy & Sinus Headache, Robitussin Nighttime Multi-Symptom Cold, Sudafed PE Severe Cold, Theraflu Severe Cold & Cough Nighttime, Theraflu Warming Flu & Sore Throat, Theraflu Warming Severe Cold Nighttime, Theraflu Warming Sinus & Cold)?
Diphenhydramine 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).
The combination of acetaminophen, diphenhydramine, and phenylephrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.
Acetaminophen, diphenhydramine, and phenylephrine may also be used for purposes not listed in this medication guide.
What are the possible side effects of acetaminophen, diphenhydramine, and phenylephrine?
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 a serious side effect such as:
Less serious side effects may include:
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, diphenhydramine, and phenylephrine?
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.
You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.
Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen and can increase certain side effects of diphenhydramine.
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.
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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