MUCINEX® Nasal Congestion + Allergy Relief

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
weekly-update
Hydrated at
2026-07-17 21:41:45

Label at a glance#

ProductMucinex Nasal Congestion and Allergy Relief
Active ingredientFLUTICASONE PROPIONATE
Label structure11 sections

Indications and uses

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: ■ nasal congestion ■ itchy nose ■ runny nose ■ itchy, watery eyes ■ sneezing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Fluticasone propionate (glucocorticoid)' 50 mcg

OTC - PURPOSE SECTION

Fluticasone propionate (glucocorticoid)' 50 mcg ..... ................. ................. .. ....... Allergy symptom reliever

Uses

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
■ nasal congestion ■ itchy nose ■ runny nose ■ itchy, watery eyes ■ sneezing

WARNINGS SECTION


Warnings
Only for use in the nose. Do not spray into your eyes or mouth.


Do not use
■ in children under 4 years of age
■ to treat asthma
■ if you have an injury or surgery to your nose that is not fully healed
■ if you have ever had an allergic reaction to this product or any of the ingredients


Ask a doctor before use if you have or had glaucoma or cataracts


Ask a doctor or pharmacist before use if you are taking
■ medicine for HIV infection (such as ritonavir)
■ a steroid medicine for asthma, allergies or skin rash
■ ketoconazole pills (medicine for fungal infection)


When using this product
■ the growth rate of some children may be slower
■ stinging or sneezing may occur for a few seconds right after use
■ do not share this bottle with anyone else as this may spread germs
■ remember to tell your doctor about all the medicines you take, including this one


Stop use and ask a doctor if
■ you have, or come info contact with someone who has, chicken pox, measles or tuberculosis
■ your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe
facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.
■ you get a constent whistling sound from your nose. This may be a sign of damage inside your nose.
■ you get an allergic reaction to this product. Seek medical help right away.
■ you get new changes to your vision that develop after sterting this product
■ you have severe or frequent nosebleeds

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


II pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION


Directions
■ read the Quick Start Guide for how to:
■ prime the bottle ■ use the spray
■ clean the spray nozzle
■ shake gently before each use
■ use this product only once a day
■ do not use more than directed


ADULTS AND CHILDREN 12 YEARS
OF AGE AND OLDER

■ Week 1 - use 2 sprays in each nostril once daily
■ Week 2 through 6 months - use 1 or 2 sprays
in each nostril once daily, as needed to treat
your symptoms
■ After 6 months of daily use - ask your doctor if
you can keep using


CHILDREN 4 TO 11 YEARS OF AGE
■ the growth rate of some children may be slower
while using this product. Children should use
for the shortest amount of time necessary
to achieve symptom relief. Talk to your
child's doctor if your child needs to use the
spray for longer than two months a year.

■ an adult should supervise use
■ use 1 spray in each nostril once daily


CHILDREN UNDER 4 YEARS OF AGE
■ do not use


IMPORTANT: Read Drug Facts on package and enclosed materials for important information.
Children 4-11: 1 spray per nostril per day.
Talk to a doctor if your child needs to use for longer than two months a year.
Keep out of reach of children.
Only for use in the nose, do not spray into eyes. Store between 4°-30°C l39°-86°F).
Shake gently before each use.

OTHER SAFETY INFORMATION


Other information
■ you may start to feel relief the first day and
full effect after several days of regular,
once-a-day use
■ store between 4' and 30'C (39' and BB'F)
■ keep this package and enclosed materials.
They contein important additional information.

INACTIVE INGREDIENT SECTION


Inactive ingredients
benzalkonium chloride, dextrose anhydrous,
microcrystalline cellulose and
carboxymethylcellulose sodium, phenylethyl
alcohol, polysorbate 80, puritied water

OTC - QUESTIONS SECTION


Questions?1-866-MUCINEX
(1-866-682-4639)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full carton labelfull carton label

back labelback label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
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9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-22772854-227-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-07monthly-update2026-06-03 17:51:35

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217088-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10c2088c7a36db…
2026-09-14 22:38:342026-08A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-1084e616aacf4f…
2026-08-18 06:07:402026-07A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-101e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10a50c72e98297…

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 Nasal Congestion and Allergy ReliefFLUTICASONE PROPIONATEReckitt Benckiser LLC47d8bb65-0bff-f24d-e063-6394a90affaf2026-05-20WarningsExact identifier
ndc (package): 72854-227-60
ndc (product): 72854-227
ndc11 (package): 72854022760
spl id: 524c152c-edac-3136-e063-6294a90a93da
spl set id: 47d8bb65-0bff-f24d-e063-6394a90affaf

Reported adverse events (FAERS/openFDA)#

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