Mucinex® NASAL SPRAYMoisture Smart®

Mucinex by

Drug Labeling and Warnings

Mucinex by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MUCINEX  MOISTURE SMART- oxymetazoline hydrochloride solution 
RB Health (US) LLC

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.

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Mucinex®
NASAL SPRAY
Moisture Smart®

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
• thyroid disease
• high blood pressure
• 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

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other information

• store between 20-25°C (68-77°F)
• retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

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 - 30 mL Bottle Carton

33% MORE!

NDC: 63824-124-01

Mucinex®

NASAL SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

Moisture
Smart®

MEMBRANE HYDRATION
TECHNOLOGY®

NEW FORMULA
& BOTTLE

✓ Soothes
membranes & clears
out excess mucus

✓ Fast Relief
of sinus pressure
& nasal congestion

12
HOUR

1 FL OZ (30 mL)

MUCINEX   MOISTURE SMART
oxymetazoline hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-124
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY)	Oxymetazoline Hydrochloride	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-124-01	1 in 1 CARTON	07/01/2011	12/31/2019
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/01/2011	12/31/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 11/2019

Document Id: 2195ed95-66ea-4b27-8d7e-3067e3e3a86f

34390-5

Set id: 2627d0a0-7382-4e90-ba00-911d3be11195

Version: 3

Effective Time: 20191122