FDA.reportPublic FDA data

MUCINEX® SINUS-MAX® SEVERE NASAL CONGESTION RELIEF SINUS & ALLERGY NASAL SPRAY

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:57:18

Label at a glance#

ProductMUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGY
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, push down firmly and turn cap counterclockwise. Before using for the first time, remove the protective cap ...

Storage and handling

store at 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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, 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.

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION


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

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

PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-120-11

Mucinex®
SINUS-MAX®

SEVERE
NASAL CONGESTION
RELIEF

SINUS & ALLERGY

NASAL SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

  • Fast acting
  • Lasts 12 Hours

3/4 FL OZ (22 mL)

LabelLabel

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363824995083GTIN-13: 0363824995083
EAN-13: 0363824995083
GTIN-12: 363824995083
UPC-A: 363824995083
GTIN storage (14 digits): 00363824995083		Mucinex Sinus Allergy Nasal Spray AW Update.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-120-11MUCINEX SINUS-MAXSEVERE CONGESTION RELIEF SINUS and ALLERGY22 mL in 1 BOTTLE, PUMPSOLUTION226
63824-120-11MUCINEX SINUS-MAXSEVERE CONGESTION RELIEF SINUS and ALLERGY1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-120-11ML - Milliliter63824-1201e07724d-f132-42e1-b1ad-39ba82e14e3d12020-05-08

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-12063824-120-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB

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 SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC41b8cead-92a0-47d8-8079-4fb5d18bf2492026-05-13WarningsExact identifier
ndc (package): 63824-120-11
ndc (product): 63824-120
ndc11 (package): 63824012011
spl id: 51b4b925-d218-f58e-e063-6394a90a20a0
spl set id: 41b8cead-92a0-47d8-8079-4fb5d18bf249

Reported adverse events (FAERS/openFDA)#

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