Acetaminophen 325 mg and Dextromethorphan HBr 10 mg Oral Liquid Day Time Kids

FDA Drug Profile — ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER

Acetaminophen 325 mg and Dextromethorphan HBr 10 mg Oral Liquid Day Time Kids is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER. Available dosage form: liquid.

Drug Details

Generic Name
Acetaminophen 325 mg and Dextromethorphan HBr 10 mg Oral Liquid Day Time Kids
Brand Names
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER
Application Number
M012
Sponsor
MEDWISE LIFESCIENCES INC.
NDC Codes
1
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN

Indications and Usage

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (20 mL each) in 24 hrs, which is the maximum daily amount for this product child takes more than 4 doses (10 mL each) in 24 hrs, 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.