Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl

FDA Drug Profile — Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg

Drug Details

Generic Name
Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl
Brand Names
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg
Application Number
M012
Sponsor
Softgel Healthcare Private Limited
NDC Codes
2
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses • temporarily relieves these symptoms due to a cold or flu: • minor aches and pains • headache • cough •sore throat • nasal and sinus congestion •temporarily reduces fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: • skin reddening • blisters • rash • hives • facial swelling • asthma (wheezing) • shock If a skin or general allergic 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.