Label: CHILDRENS FLONASE ALLERGY RELIEF- fluticasone propionate spray, metered
Contains inactivated NDC Code(s)
NDC Code(s): 0135-0582-01, 0135-0582-02, 0135-0582-03
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated March 1, 2016
If you are a consumer or patient please visit this version.
- Active Ingredient (in each spray)
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 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
- 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
- Inactive ingredients
- Questions or comments?
Principal Display Panel
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
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.
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.
These symptoms can be triggered by allergens like pollen, mold, dust or pet dander.
Blister card: 104854XA
- Peel Back Label: 104448XB ©2015 GSK
INGREDIENTS AND APPEARANCE
CHILDRENS FLONASE ALLERGY RELIEF
fluticasone propionate spray, metered
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0582 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE PROPIONATE 50 ug Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0582-01 1 in 1 PACKAGE 02/29/2016 1 60 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:0135-0582-02 2 in 1 PACKAGE 02/29/2016 2 60 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:0135-0582-03 1 in 1 CARTON 06/30/2016 3 30 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205434 02/29/2016 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)