ALLERGY RELIEF- fluticasone propionate spray, metered 
Quality Home Products

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Drug Facts

Active ingredient (in each spray)

Fluticasone propionate (glucocorticoid) 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

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 or comments?

call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time

Principal Display Panel - Bottle 60ms

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Allergy Relief

Fluticasone Propionate Nasal Spray, USP

50 mcg per spray (Glucocorticoid)­

60 metered sprays

Allergy Symptom Reliever Nasal Spray

Bottle-label-60ms

Principal Display Panel - Carton 60ms

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray 

Allergy Relief

Fluticasone Propionate Nasal Spray, USP ­

60 metered sprays 

50 mcg per spray (Glucocorticoid)

­Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

Carton-60ms

ALLERGY RELIEF 
fluticasone propionate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64525-8000
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)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64525-8000-11 in 1 CARTON04/17/201804/06/2024
160 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20815004/17/201804/06/2024
Labeler - Quality Home Products (205554157)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc.255092496analysis(64525-8000) , manufacture(64525-8000)
Establishment
NameAddressID/FEIBusiness Operations
Legacy Pharmaceutical Packaging, LLC143213275pack(64525-8000)
Establishment
NameAddressID/FEIBusiness Operations
HOVIONE FARMACIENCIA, S.A449818434api manufacture(64525-8000)

Revised: 8/2022
Document Id: 74d8f26a-a4ea-5ff2-e013-34bc4f404626
Set id: 1f24571e-7982-2fb6-c9d2-daa4b1cd8d1d
Version: 3
Effective Time: 20220815
 
Quality Home Products