FLUTICASONE PROPIONATE- fluticasone propionate spray, metered 
Allegiant Health

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448 - Fluticasone Propionate Nasal Spray 72 Metered Spray

Active ingredient(s)

Fluticasone propionate (glucocorticoid) 50 mcg per spray

Purpose

Allergy symptom reliever 

Use(s)

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

have or had glaucoma or cataracts.

Ask a doctor or pharmacist before use if

  • 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 breastfeeding,

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 (1-800-222-1222) right away.

Directions

read the Quick Start Guide for how to:

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

CHILDREN 4 to 11 YEARS OF AGE

CHILDREN UNDER 4 YEARS OF AGE

do not use

Other information

Inactive ingredients

0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water

Questions/Comments

Call 1-888-952-0050 Monday through Friday 9AM to 5PM EST

Principal Display Panel

Fluticasone Propionate

Fluticasone Propionate

Fluticasone Propionate Label

Fluticasone Propionate Label

FLUTICASONE PROPIONATE 
fluticasone propionate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-448
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 (UNII: IY9XDZ35W2)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-448-011 in 1 CARTON12/10/2023
172 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07753812/10/2023
Labeler - Allegiant Health (079501930)

Revised: 11/2023
Document Id: 1f772537-33ec-4be3-b542-9160056eceac
Set id: a4e1c265-5205-4089-8190-0755ede83896
Version: 2
Effective Time: 20231128
 
Allegiant Health