Mucinex® Sinus-Max™ Full Force Nasal Spray

Manufacturer
RB Health (US) LLC
Effective date
2019-08-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:13:48

Label at a glance#

ProductMucinex Sinus-Max Full Force
Active ingredientOxymetazoline Hydrochloride
Label structure11 sections

Indications and 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

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: 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 ...

Storage and handling

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

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
    • 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
  • trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms 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: 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

STORAGE AND HANDLING SECTION

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

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 phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-127-75

Mucinex®
SINUS-MAX™

Nasal Spray
Oxymetazoline HCl 0.05%
Nasal Decongestant

FULL
FORCE
®
CONCENTRATED VAPOR
TECHNOLOGY
®

12
HOUR

  • Powerful
    mucus-moving
    sensation
  • Fast Relief
    of sinus pressure
    & nasal congestion

3/4 FL OZ (22 mL)

PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-127-75ML - Milliliter63824-127f7f22bbf-b17d-4999-9c01-91dbb576722e12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Oxymetazoline HydrochlorideACTIVE INGREDIENTK89MJ0S5VY1
OxymetazolineACTIVE MOIETY8VLN5B44ZY1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W71
edetate disodiumINACTIVE INGREDIENT7FLD91C86K1
eucalyptolINACTIVE INGREDIENTRV6J6604TK1
glycineINACTIVE INGREDIENTTE7660XO1C1
mentholINACTIVE INGREDIENTL7T10EIP3A1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
sodium chlorideINACTIVE INGREDIENT451W47IQ8X1
sodium hydroxideINACTIVE INGREDIENT55X04QC32I1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-12763824-127-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 11 · 619 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HDROPS / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / RESPIRATORY (INHALATION)108 mgExact identifier — unii candidate
134 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycineGLYCINETE7660XO1CTABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
20 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
glycineGLYCINETE7660XO1CINJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACARDIAC70 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / TOPICAL0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / PERIODONTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IDROPS / OPHTHALMICNAExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, COATED / ORAL0.08 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / ENDOTRACHEAL68 mgExact identifier — unii candidate
134 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / EPIDURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / ORAL11 mgExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / AURICULAR (OTIC)13 mgExact identifier — unii candidate
78 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / ORAL400 mgExact identifier — unii candidate
174 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1800 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
mentholMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycineGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.5 mgExact identifier — unii candidate
20 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SOLUTION / OPHTHALMIC0.9 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii candidate
78 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates

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
2f8a31a1-17c0-4492-83e5-bd1edc0593f2832fdcfe-b5a9-47bf-bb04-16a6b0f3789d2019-08-29WarningsExact identifier
spl id: 2f8a31a1-17c0-4492-83e5-bd1edc0593f2
spl set id: 832fdcfe-b5a9-47bf-bb04-16a6b0f3789d

Reported adverse events (FAERS/openFDA)#

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