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FLONASE SENSIMIST ALLERGY RELIEF

Medically reviewed on March 23, 2017

Dosage form: spray, metered
Ingredients: FLUTICASONE FUROATE 27.5ug
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0616

Drug Facts

Active ingredient (in each spray)

Fluticasone furoate 27.5 mcg (glucocorticold)*

*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° and 30°C (59° and 86°F)
do not refrigerate or freeze
keep this label and enclosed materials. They contain important additional information.

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

NDC 0135-0616-01

CHILDREN’s

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:

Nasal Congestion
Runny Nose
Itchy Nose
Sneezing

24 HOUR RELIEF

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

60 METERED SPRAYS

0.20 fl oz (5.9 mL)

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

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

Distirbuted 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.

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

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

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

Outdoor allergens

Animal allergens

Indoor allergens

 
Backer card: 105625XA
 
Peel Back Label: 105629XA
FLONASE SENSIMIST  ALLERGY RELIEF
fluticasone furoate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0616
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE FUROATE (FLUTICASONE) FLUTICASONE FUROATE27.5 ug
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
ANHYDROUS DEXTROSE 
EDETATE DISODIUM 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
WATER 
Packaging
#Item CodePackage Description
1NDC:0135-0616-011 BOTTLE in 1 PACKAGE
160 SPRAY, METERED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02205107/01/2017
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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