ACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl

FDA Drug Profile — BACZOL COLD MEDICINE

Drug Details

Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl
Brand Names
BACZOL COLD MEDICINE
Application Number
M012
Sponsor
Procaps S.A. de C.V.
NDC Codes
1
Dosage Forms
SYRUP
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

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.