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Mucinex Nasal Moisture Smart

Dosage form: solution
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05g in 100mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-122

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Mucinex®
Nasal Spray

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses
  • temporarily relieves nasal congestion due to:
    • a cold
    • hay fever
    • upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes

Warnings

Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product
  • do not use more than directed
  • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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: ask a doctor Shake well before use. Before using 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 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.

Other information
  • store between 15-30°C (59-86°F)
  • retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride, edetate disodium, glycerin, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sorbitol

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton

ORIGINAL FORMULA

NDC 63824-122-75

Mucinex®
NASAL SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

Moisture
Smart®

MEMBRANE HYDRATION
TECHNOLOGY®

Soothes
membranes & clears
out excess mucus
Fast Relief
of sinus pressure
& nasal congestion

12
HOUR

3/4 FL OZ (22 mL)

MUCINEX  NASAL MOISTURE SMART
oxymetazoline hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-122
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
SORBITOL 
Packaging
#Item CodePackage Description
1NDC:63824-122-751 BOTTLE (BOTTLE) in 1 CARTON
122 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/20/2011
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 12/2011
 
Reckitt Benckiser LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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