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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 1, 2016

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each spray)

    Fluticasone propionate (glucocorticold) 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, phenylethylalcohol, polysorbate 80, purified water, sodium carboxymethylcellulose

  • Questions or comments?

    call toll-free 1-844-FLONASE (1-844-356-6273) (English/Spanish) weekdays

  • Principal Display Panel

    NDC 0135-0582-01

    CHILDREN’S

    FLONASE®

    ALLERGY RELIEF

    FULL PRESCRIPTION STRENGTH • NON-DROWSY

    Fluticasone Propionate (Glucocorticoid) 50 mcg Per Spray

    Allergy Symptom Reliever Nasal Spray

    24 Hour Relief of:

    Itchy, Watery Eyes
    Nasal Congestion
    Runny Nose
    Itchy Nose
    Sneezing

    24HOUR RELIEF

    60 METERED SPRAYS

    0.34 fl oz (9.9 mL)

    ©2015 the GSK group of companies or its licensor. All rights reserved.

    FLONASE, the FLONASE logo, the bottle and cap designs, and other design elements are trademarks owned by or licensed to the GSK group of companies.

    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.

    Distributed by:

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Township, PA 15108

    Made in Canada

    What problems can FLONASE® Allergy Relief help with

    FLONASE® Allergy Relief helps relieve a broad range of uncomfortable symptoms like congestion and itchy eyes.

    Nasal symptoms

    Eye symptoms

    These symptoms can be triggered by allergens like pollen, mold, dust or pet dander.

    Outdoor allergens

    Animal allergens

    Indoor allergens

    Blister card: 104854XA

     
    Peel Back Label: 104448XB ©2015 GSK
    Flonase Childrens 60 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 (UNII: IY9XDZ35W2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0582-011 in 1 PACKAGE02/29/2016
    160 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0135-0582-022 in 1 PACKAGE02/29/2016
    260 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:0135-0582-031 in 1 CARTON06/30/2016
    330 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)