Acetaminophen, Dextromethrophan HBr, Guaifenesin, Phenylephrine HCl

FDA Drug Profile — Severe Cold and Flu Daytime Honey

Drug Details

Generic Name
Acetaminophen, Dextromethrophan HBr, Guaifenesin, Phenylephrine HCl
Brand Names
Severe Cold and Flu Daytime Honey
Application Number
M012
Sponsor
Kroger
NDC Codes
1
Dosage Forms
LIQUID
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 passageways of bothersome mucus and make coughs more productive.

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product child 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.