ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE

FDA Drug Profile — Nighttime Severe Cold and Cough, Quality Choice Severe Cold and Cough Nighttime, Severe Cold and Cough Nighttime, Nighttime Wal Flu Severe Cold and Cough

Drug Details

Generic Name
ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
Brand Names
Nighttime Severe Cold and Cough, Quality Choice Severe Cold and Cough Nighttime, Severe Cold and Cough Nighttime, Nighttime Wal Flu Severe Cold and Cough
Application Number
M010
Sponsor
KROGER COMPANY
NDC Codes
5
Dosage Forms
POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation 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 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.