Acetaminophen and Guaifenesin

FDA Drug Profile — Mucinex Sinus Max Clear and Cool

Drug Details

Generic Name
Acetaminophen and Guaifenesin
Brand Names
Mucinex Sinus Max Clear and Cool
Application Number
M012
Sponsor
RB Health (US) LLC
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, GUAIFENESIN

Indications and Usage

Uses ■ temporarily relieves nasal congestion due to: ■ a cold ■ hay fever or other upper respiratory allergies ■ promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure ■ helps clear nasal passages; shrinks swollen membranes 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 Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland When using this product ■ do not exceed recommended dosage ■ do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. ■ this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge ■ the use of this container by more than one person may spread infection Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 12 capsules in 24 hours, which is the maximum daily amount for this product ■ 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. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.