Doxylamine Succinate and Phenylephrine Hydrochloride

FDA Drug Profile — Poly Hist Forte

Doxylamine Succinate and Phenylephrine Hydrochloride is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Poly Hist Forte. Available dosage form: tablet.

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 common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation Cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores free breathing through the nose promotes nasal and/or sinus drainage

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product 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 If a skin 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.