Acetaminophen, Doxylamine succinate and Dextromethorphan HBr

FDA Drug Profile — NIGHTTIME COLD AND FLU

Drug Details

Generic Name
Acetaminophen, Doxylamine succinate and Dextromethorphan HBr
Brand Names
NIGHTTIME COLD AND FLU
Application Number
M012
Sponsor
BI-MART
NDC Codes
1
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

Indications and Usage

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

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product • taken with other drugs containing acetaminophen • adult has 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, lasts for mroe than 2 days, is accompanied or followed by fever, heacache, rash, nausea, or vomiting, consult a doctor promptly.