MUCINEX CHILDRENS STUFFY NOSE- 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® Children's Stuffy Nose Spray

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

Warnings

Ask a doctor before use if you or the child has

  • 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

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

Shake well before use. To open, hold by the white grips then squeeze and turn cap. 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 until it "clicks".

DO NOT DISCARD CAP

Other information

Inactive ingredients

benzalkonium chloride, camphor, edetate disodium, eucalyptol, glycine, menthol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium chloride, sodium hydroxide

Questions?

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

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in India

PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton

NDC 63824-961-22

Mucinex®

Children's

STUFFY NOSE
SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

12
HOUR

Fast Relief
of Stuffy Nose

Ages 6+
yrs

3/4 FL OZ (22 mL)
NASAL SPRAY

PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton
MUCINEX CHILDRENS STUFFY NOSE 
oxymetazoline hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-961
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride (UNII: F5UM2KM3W7)  
edetate disodium (UNII: 7FLD91C86K)  
eucalyptol (UNII: RV6J6604TK)  
glycine (UNII: TE7660XO1C)  
menthol, unspecified form (UNII: L7T10EIP3A)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium chloride (UNII: 451W47IQ8X)  
sodium hydroxide (UNII: 55X04QC32I)  
camphor (synthetic) (UNII: 5TJD82A1ET)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-961-221 in 1 CARTON03/30/2018
122 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/30/2018
Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022
Document Id: 18b24923-8613-451f-b62c-0bdeae626a4d
Set id: de1c0abd-1644-4351-8106-e9df6ca5c142
Version: 4
Effective Time: 20220111
 
RB Health (US) LLC