Label: CHILDRENS FLONASE ALLERGY RELIEF- fluticasone propionate spray, metered

  • NDC Code(s): 0135-0582-04
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 29, 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° and 30°C (39° and 86°F)
    •
    keep this label and enclosed materials. They contain important additional information.
  • Inactive ingredients

    benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water, sodium carboxymethylcellulose

  • Questions or comments?

    call toll-free 1-844-FLONASE (1-844-356-6273)

  • Principal Display Panel

    NDC 0135-0582-04

    CHILDREN’S

    FLONASE

    ALLERGY RELIEF

    FULL PRESCRIPTION STRENGTH • NON-DROWSY

    Fluticasone Propionate Nasal Spray 50 mcg Per Spray

    Allergy Symptom Reliever

    (Glucocorticoid)*

    24 Hour Relief of:

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

    *Fluticasone propionate is a steroid medicine known as a glucocorticoid.

    24 HOUR RELIEF

    AGES 4 YEARS & OLDER

    72 METERED SPRAYS

    0.38 fl oz (11.1 mL)

    IMPORTANT – Peel here for complete Drug Facts label. Children 4-11: do not use for more than 2 months a year.

    Be sure to read the Quick Start Guide and Question & Answer Book inside package

    TAMPER-EVIDENT features for your protection.

    The product is packaged in a sealed plastic container. Under the cap and nozzle, each bottle has an aluminum seal around bottle neck.

    Do not use if any of these features are torn or damaged.

    ©2019 GSK group of companies or its licensor.

    Trademarks are owned by or licensed to the GSK group of companies.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

     
    Peel Back Label: 104448XC
    1000638 Flonase Childrens 72 dose inlay card
  • INGREDIENTS AND APPEARANCE
    CHILDRENS FLONASE  ALLERGY RELIEF
    fluticasone propionate spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0582
    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)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0582-041 in 1 PACKAGE02/29/2016
    172 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
    NDANDA20543402/29/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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