acetaminophen, dextromethorphan hbr, diphenhydramine hcl

FDA Drug Profile — Theraflu Severe Cold Relief Combo Pack

acetaminophen, dextromethorphan hbr, diphenhydramine hcl is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Theraflu Severe Cold Relief Combo Pack. Available dosage form: kit.

Drug Details

Generic Name
acetaminophen, dextromethorphan hbr, diphenhydramine hcl
Brand Names
Theraflu Severe Cold Relief Combo Pack
Application Number
M012
Sponsor
Haleon US Holdings LLC
NDC Codes
2
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

Uses - Daytime Severe Cold Relief ▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever Uses - Nighttime Severe Cold Relief ▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ runny nose ▪ sneezing ▪ itchy nose or throat ▪ itchy, watery eyes due to hay fever ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever

Warnings

Warnings – Daytime Severe Cold Relief /Nighttime Severe Cold Relief 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 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.