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Drug Facts
Mucinex Sinus Max Sinus Pressure Severe Congestion Spray
FDA Label NDC 72854-219
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Sinus Max Sinus Pressure Severe Congestion (NDC 72854-219). 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 other, otc - active ingredient, indications & usage, otc - purpose, warnings, dosage & administration, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Oxymetazoline hydrochloride 0.05%
Indications & Usage
Purpose:
Nasal Decongestant
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
Otc - Purpose
Purpose:
Nasal Decongestant
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
Stop use and ask a doctor if symptoms persist
Dosage & Administration
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional
before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.
Other Safety Information
Other information
■ store at 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
benzalkonium chloride,
benzododecinium chloride,
cetalkonium chloride, dibasic
sodium phosphate anhydrous,
edetate disodium, glycerin,
monobasic sodium phosphate
anhydrous, myristalkonium
chloride, phosphorous pentoxide,
propylene glycol, purified water,
sodium oxide, sorbitol
Otc - Questions
Questions?
1-866-MUCINEX (1-866-682-4639)
Dist. by: RB Health (US)
Parsippany NJ 07054-0224
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