Label: MUCINEX NASAL CONGESTION AND ALLERGY RELIEF- fluticasone propionate spray, metered
- NDC Code(s): 72854-227-60
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 7, 2026
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
-
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
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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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MUCINEX NASAL CONGESTION AND ALLERGY RELIEF
fluticasone propionate spray, meteredProduct 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)


