Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCI

FDA Drug Profile

Drug Details

Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCI
Brand Names
N/A
Application Number
Sponsor
RB Health (US) LLC
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
N/A
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (15 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.