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

  • 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.

  • 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

    full carton label

    back label

  • INGREDIENTS AND APPEARANCE
    MUCINEX NASAL CONGESTION AND ALLERGY RELIEF 
    fluticasone propionate spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-227
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE PROPIONATE50 ug
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-227-601 in 1 CARTON07/01/2025
    160 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21708807/01/2025
    Labeler - RB Health (US) LLC (081049410)