Acetaminophen, Dextromethorphan HBr, Doxylamine succinate softgels

FDA Drug Profile — Nighttime Ultra Concentrated Cold and Flu

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate softgels is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Nighttime Ultra Concentrated Cold and Flu. Available dosage form: capsule, liquid filled.

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
DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, 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.