The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Sinus-max (NDC 63824-129). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient Purpose
Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant
Active ingredients (in each capsule) Purposes
Acetaminophen 325 mg.........................................Pain reliever/fever reducer
Guaifenesin 200 mg...................................................................Expectorant
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
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.
Directions
■ adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each
nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
■ children under 6 years of age: consult a doctor.
Shake well before use.
To open, hold by the white grips then squeeze, push down firmly and turn cap counterclockwise.
Before using for the first time, remove the protective cap from the tip and prime metered pump
by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle
between first and second fingers.Without tilting head, insert nozzle into nostril. Fully depress
pump all the way down with a firm even stroke and sniff deeply.Wipe nozzle clean after use.
To close, turn cap clockwise.
DO NOT DISCARD CAP.
Directions
■ do not take more than directed (see Overdose warning)
■ do not take more than 12 capsules in any 24-hour period
■ adults and children 12 years of age and over: take 2 capsules every 4 hours
■ children under 12 years of age: do not use
Other information
■ store at 20-25°C (68-77°F)
■ avoid excessive heat
Inactive ingredients
benzalkonium chloride, benzododecinium chloride, camphor, cetalkonium chloride, colloidal
silicon dioxide, edetate disodium, eucalyptol, glycine, linoleic acid, linolenic acid, menthol,
myristalkonium chloride, myristic acid, oleic acid, palmitic acid, palmitoleic acid, polyethylene
glycol, polysorbate 80, propylene glycol, purified water, sodium carbonate, sodium chloride,
sodium hydroxide, stearic acid
Inactive ingredients
FD&C blue no.1, gelatin, glycerin, hypromellose, lecithin, light mineral oil, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Keep out of reach of Children
Purpose
Oxymetazoline hydrochloride 0.05%.........................................Nasal decongestant
Acetaminophen 325 mg.........................................Pain reliever/fever reducer
Guaifenesin 200 mg...................................................................Expectorant
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