MUCINEX NASAL CONGESTION AND ALLERGY RELIEF- fluticasone propionate spray, metered

Mucinex Nasal Congestion and Allergy Relief by

Drug Labeling and Warnings

Mucinex Nasal Congestion and Allergy Relief by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Fluticasone propionate (glucocorticoid)' 50 mcg

PURPOSE

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

Uses

Uses

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

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

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

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

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCINEX NASAL CONGESTION AND ALLERGY RELIEF 
fluticasone propionate spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-227
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)	FLUTICASONE PROPIONATE	50 ug

Inactive Ingredients
Ingredient Name	Strength
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-227-60	1 in 1 CARTON	07/01/2025
1		60 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217088	07/01/2025

Labeler - RB Health (US) LLC (081049410)