acetaminophen, chlorpheniramine maleate, and phenylephrine HCl

FDA Drug Profile — Norel AD

Drug Details

Generic Name
acetaminophen, chlorpheniramine maleate, and phenylephrine HCl
Brand Names
Norel AD
Application Number
M012
Sponsor
U.S. PHARMACEUTICAL CORPORATION
NDC Codes
1
Dosage Forms
TABLET, MULTILAYER
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses Temporarily relieves these symptoms due to the common cold or flu nasal congestion runny nose minor aches and pains headache sore throat sneezing itchy, watery eyes itching of the nose or throat sinus congestion and pressure temporarily reduces fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 6 tablets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours 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 reaction. 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, speak with a healthcare provider.