Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate

FDA Drug Profile — Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate, VICKS FORMULA 44DM NIGHTTIME COUGH and COLD

Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate, VICKS FORMULA 44DM NIGHTTIME COUGH and COLD. Available dosage forms: kit, liquid.

Drug Details

Generic Name
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate
Brand Names
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate, VICKS FORMULA 44DM NIGHTTIME COUGH and COLD
Application Number
M012
Sponsor
CVS Pharmacy, Inc
NDC Codes
2
Dosage Forms
KIT, LIQUID
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE

Indications and Usage

Uses • Temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever • nasal congestion due to the common cold • Calms the cough control center and relieves coughing • minor aches and pains associated with the common cold • temporarily reduces fever.

Warnings

Warnings: Liver warning: This product contains acetaminophen • Severe liver damage may occur if • adult takes more than 6 doses in 24 hours, which is the maximum daily amount •child takes more than 6 doses in 24 hours • taken with other drugs containing acetaminophen• adult has 3 or more alcoholic drinks every day while using this product • Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician.