Label: ALLERGY RELIEF- fluticasone propionate spray, metered

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 13, 2022

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  • Active ingredient (in each spray)

    Fluticasone propionate (glucocorticoid) 50 mcg.

  • Purpose

    Allergy symptom reliever

  • Uses

    Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

    • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

  • 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 into 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 constant 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 starting this product
    • you have severe or frequent nosebleeds

    If 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.

  • 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

  • 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° to 30°C (39° to 86°F)
    • keep this label and enclosed materials. They contain important additional information.
  • Inactive ingredients

    0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water

  • Questions or comments?

    call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time

  • Principal Display Panel - Carton

    CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

    TOPCO NDC 76162-656-1

    Allergy Relief

    Fluticasone Propionate Nasal Spray, USP

    72 metered sprays

    50 mcg per spray (Glucocorticoid)

    Allergy Symptom Reliever Nasal Spray

    24 Hour Relief of:

    • Itchy, Watery Eyes
    • Nasal Congestion
    • Runny Nose
    • Itchy Nose
    • Sneezing

    72MD ctn label

  • Principal Display Panel - Bottle

    BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

    TOPCO NDC 76162-656-1

    Allergy Relief

    Fluticasone Propionate Nasal Spray, USP

    72 metered sprays

    50 mcg per spray (Glucocorticoid)

    Allergy Symptom Reliever Nasal Spray

    72MD btl label

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    fluticasone propionate spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-656
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-656-011 in 1 CARTON01/13/2022
    172 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20815001/13/2022
    Labeler - Topco Associates LLC (006935977)
    Registrant - Apotex Inc. (209429182)
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