Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr

FDA Drug Profile — Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr

Drug Details

Generic Name
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr
Brand Names
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr
Application Number
M012
Sponsor
Softgel Healthcare Pvt Ltd
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, 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 reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive.

Warnings

Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.