ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HBr 10 mg PHENYLEPHRINE HCI 5 mg

FDA Drug Profile — MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME

Drug Details

Generic Name
ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HBr 10 mg PHENYLEPHRINE HCI 5 mg
Brand Names
MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME
Application Number
M012
Sponsor
RITE AID
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 8 softgels in 24 hours, 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.