Label: FLONASE SENSIMIST ALLERGY RELIEF- fluticasone furoate spray, metered

  • NDC Code(s): 0135-0615-01, 0135-0615-02, 0135-0615-03, 0135-0615-04, view more
    0135-0615-05, 0135-0615-06
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 30, 2019

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

  • Active ingredient (in each spray)

    Fluticasone furoate 27.5 mcg (glucocorticoid)*

    *read the Question & Answer Book

  • 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 (for ages 12 and older)
  • Warnings

    Only for use in the nose. Do not spray into your eyes or mouth.

    Do not use

    in children under 2 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:
    shake vigorously before each use
    prime the bottle
    use the spray
    sniff gently after each spray
    clean the spray nozzle with a clean dry tissue
    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 2 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 2 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 15° – 30°C (59° – 86°F)
    do not refrigerate or freeze
    keep this label and enclosed materials. They contain important additional information.
  • Inactive ingredients

    benzalkonium chloride solution, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium, microcrystalline cellulose, polysorbate 80, purified water

  • Questions or comments?

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

  • Principal Display Panel

    NDC 0135-0615-02

    FLONASE®

    SENSIMIST™

    ALLERGY RELIEF

    GENTLE MIST • SCENT FREE • ALCOHOL FREE

    Fluticasone Furoate Nasal Spray 27.5 mcg Per Spray

    Allergy Symptom Reliever

    (Glucocorticoid)*

    Full Prescription Strength Non-Drowsy 24 Hour Relief of:

    Itchy, Watery Eyes
    Nasal Congestion
    Runny Nose
    Itchy Nose
    Sneezing

    24 HOUR RELIEF

    60 METERED SPRAYS

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

    0.34 fl oz (9.9 mL)

    ©2017 GSK group of companies or its licensor. All rights reserved.

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

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    Made in Singapore

    IMPORTANT – Peel here for complete Drug Facts label. Children 2-11: 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. The bottle is housed within a plastic dispenser that prevents direct access to the bottle. Do not use if the container or any part of the plastic dispenser, including the dispenser bottom, is damaged or broken.

    What problems can FLONASE® SENSIMIST™ Allergy Relief help with?

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

    Nasal symptoms

    Eye symptoms*

    *for ages 12 and older.

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

    Outdoor allergens

    Animal allergens

    Indoor allergens

     
    Peel Back Label: 105629XA
     
    Blister Card Front: 105621XC
    105621XC_Flonase Sensimist_60 ct.JPG
  • INGREDIENTS AND APPEARANCE
    FLONASE SENSIMIST  ALLERGY RELIEF
    fluticasone furoate spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0615
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUTICASONE FUROATE (UNII: JS86977WNV) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE FUROATE27.5 ug
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0615-011 in 1 CARTON02/01/2017
    130 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0135-0615-021 in 1 PACKAGE02/01/2017
    260 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:0135-0615-031 in 1 PACKAGE02/01/2017
    3120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4NDC:0135-0615-043 in 1 PACKAGE02/01/2017
    4120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    5NDC:0135-0615-052 in 1 PACKAGE07/01/2017
    5120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    6NDC:0135-0615-061 in 1 PACKAGE01/22/2019
    672 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
    NDANDA02205102/01/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)