Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI 325, 10, 5 mg softgels

FDA Drug Profile — Daytime cold and flu

Drug Details

Generic Name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI 325, 10, 5 mg softgels
Brand Names
Daytime cold and flu
Application Number
M012
Sponsor
TIME CAP LABORATORIES, INC.
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves common cold/flu symptoms: nasal congestion 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 you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.