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

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Drug Facts

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:

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

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

CHILDREN 2 TO 11 YEARS OF AGE

CHILDREN UNDER 2 YEARS OF AGE

Other 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:

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:

GSKConsumer 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-EVIDENTfeatures 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

105621XC_Flonase Sensimist_60 ct.JPG
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 (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 - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 14449f3e-74db-8c53-e063-6294a90a7584
Set id: 107100af-7ca2-44e8-b067-c0ab0a19a6dc
Version: 10
Effective Time: 20240322
 
Haleon US Holdings LLC