Doxylamine Succinate and Phenylephrine Hydrochloride

FDA Drug Profile — Poly Hist Forte

Drug Details

Generic Name
Doxylamine Succinate and Phenylephrine Hydrochloride
Brand Names
Poly Hist Forte
Application Number
M012
Sponsor
Poly Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms due to cold/flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening blisters rash hives facial swelling asthma(wheezing) shock If a skin or general allergic reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use to sedate children.