FLONASE  ALLERGY RELIEF- fluticasone propionate spray, metered 
Haleon US Holdings LLC

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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:

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

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

CHILDREN 4 TO 11 YEARS OF AGE

CHILDREN UNDER 4 YEARS OF AGE

Other 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 0135-0576-03

FLONASE®

ALLERGY RELIEF

FULL PRESCRIPTION STRENGTH * NON-DROWSY

Fluticasone Propionate (Glucocorticoid) 50 mcg Per Spray

Allergy Symptom Reliever Nasal Spray

24 Hour Relief of:

24 HOUR RELIEF

120 METERED SPRAYS

0.54 fl oz (15.8 mL)

FLONASE, the FLONASE logo, the bottle and cap design, and other design elements are trademarks of 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-EVIDENTfeatures 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

Flonase 120 count backcard
FLONASE   ALLERGY RELIEF
fluticasone propionate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0576
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, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0576-011 in 1 CARTON06/30/2016
130 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0135-0576-021 in 1 PACKAGE12/04/2014
260 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0135-0576-031 in 1 PACKAGE12/04/2014
3120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:0135-0576-043 in 1 PACKAGE01/07/2015
4120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC:0135-0576-122 in 1 PACKAGE02/29/2016
5120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
6NDC:0135-0576-141 in 1 PACKAGE11/17/2016
6144 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
7NDC:0135-0576-152 in 1 PACKAGE03/20/2017
7144 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
8NDC:0135-0576-163 in 1 PACKAGE03/20/2017
8144 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
9NDC:0135-0576-171 in 1 PACKAGE01/22/2019
972 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
10NDC:0135-0576-181 in 1 PACKAGE07/01/2021
1090 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
NDANDA20543412/04/2014
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 1443fcc4-bd21-6684-e063-6394a90a3b0a
Set id: b6134ba0-b70a-4eac-9a82-cef64b242c1d
Version: 19
Effective Time: 20240322
 
Haleon US Holdings LLC