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CHILDRENS FLONASE ALLERGY RELIEF

Medically reviewed on March 1, 2018

Dosage form: spray, metered
Ingredients: FLUTICASONE PROPIONATE 50ug
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0582

Drug Facts

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
CHILDRENS FLONASE  ALLERGY RELIEF
fluticasone propionate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0582
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE50 ug
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
DEXTROSE 
CELLULOSE, MICROCRYSTALLINE 
PHENYLETHYL ALCOHOL 
POLYSORBATE 80 
WATER 
CARBOXYMETHYLCELLULOSE SODIUM 
Packaging
#Item CodePackage Description
1NDC:0135-0582-011 BOTTLE in 1 PACKAGE
160 SPRAY, METERED in 1 BOTTLE
2NDC:0135-0582-022 BOTTLE in 1 PACKAGE
260 SPRAY, METERED in 1 BOTTLE
3NDC:0135-0582-031 BOTTLE in 1 CARTON
330 SPRAY, METERED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20543402/29/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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