Acetaminophen, Dextromethorphan HBr, Doxylamine succinate softgels

FDA Drug Profile — Nighttime Ultra Concentrated Cold and Flu

Drug Details

Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate softgels
Brand Names
Nighttime Ultra Concentrated Cold and Flu
Application Number
M012
Sponsor
WALGREENS
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

Indications and Usage

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Warnings

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels in 24 hours, 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.