Acetaminophen and Guaifenesin

FDA Drug Profile — Mucinex Sinus Max Clear and Cool, Mucinex Childrens Mini Melts Cold and Flu

Drug Details

Generic Name
Acetaminophen and Guaifenesin
Brand Names
Mucinex Sinus Max Clear and Cool, Mucinex Childrens Mini Melts Cold and Flu
Application Number
M012
Sponsor
RB Health (US) LLC
NDC Codes
2
Dosage Forms
CAPSULE, LIQUID FILLED, GRANULE
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, GUAIFENESIN

Indications and Usage

Uses Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily reduces fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 12 liquid gels in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily 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.