Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride

FDA Drug Profile — Cough and Cold XL3 Xtra

Drug Details

Generic Name
Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
Brand Names
Cough and Cold XL3 Xtra
Application Number
M012
Sponsor
Selder, S.A. de C.V.
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves: • muscular aches and pains • headache • temporarily reduces fever • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies • pressure • nasal congestion • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take • more than 12 tablets in 24 hours, which is the maximum daily amount • 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.