MUCINEX® Children's Stuffy Nose Spray

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:57:58

Label at a glance#

ProductMUCINEX Childrens Stuffy Nose
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

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 and turn cap. Before using for the first time, remove the protective cap from the tip and prime metered pump...

Storage and handling

store between 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor ifsymptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

Made in India

PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN6
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD6
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-961-22MUCINEX Childrens Stuffy Nose22 mL in 1 BOTTLE, PUMPSOLUTION226
63824-961-22MUCINEX Childrens Stuffy Nose1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-961-22ML - Milliliter63824-9614679f073-6f42-4fb3-bc0f-1b66ff3939e112020-03-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-96163824-961-22

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCINEX Childrens Stuffy NoseOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLCde1c0abd-1644-4351-8106-e9df6ca5c1422026-05-18WarningsExact identifier
ndc (package): 63824-961-22
ndc (product): 63824-961
ndc11 (package): 63824096122
spl id: 521a2316-8ecc-393d-e063-6294a90a8d0d
spl set id: de1c0abd-1644-4351-8106-e9df6ca5c142

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.