FLUTICASONE PROPIONATE- fluticasone propionate spray, metered 
Chain Drugs Consortium, LLC

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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 - Carton

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Chain Drug Consortium NDC 68016-723-00

Fluticasone Propionate Nasal Spray, USP

120 sprays

Allergy Symptom Reliever Nasal Spray

(Glucocorticoid)

24 Hour Relief of:

Carton-label-120md

Principal Display Panel - Bottle

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Chain Drug Consortium NDC 68016-723-00

Fluticasone Propionate Nasal Spray, USP

120 sprays

Allergy Symptom Reliever Nasal Spray

(Glucocorticoid)

Bottle-label-120md

Principal Display Panel - Carton 60md

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Chain Drug Consortium NDC 68016-723-01

Fluticasone Propionate Nasal Spray, USP

60 sprays

Allergy Symptom Reliever Nasal Spray

(Glucocorticoid)

24 Hour Relief of:

Carton-label-60md

Principal Display Panel - Bottle 60md

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Chain Drug Consortium NDC 68016-723-01

Fluticasone Propionate Nasal Spray, USP ­

60 sprays

Allergy Symptom Reliever Nasal Spray

(Glucocorticoid)

Bottle-label-60md

FLUTICASONE PROPIONATE 
fluticasone propionate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-723
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:68016-723-001 in 1 CARTON02/29/2016
1120 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:68016-723-011 in 1 CARTON09/15/2016
260 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:68016-723-022 in 1 CARTON08/07/2017
3120 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
ANDAANDA20815002/29/2016
Labeler - Chain Drugs Consortium, LLC (101668460)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc.255092496analysis(68016-723) , manufacture(68016-723)
Establishment
NameAddressID/FEIBusiness Operations
Legacy Pharmaceutical Packaging, LLC143213275pack(68016-723)

Revised: 11/2023
Document Id: 07ef6aa0-a48f-e4f2-1392-6e5e87f50399
Set id: a0ea49f0-6b33-bb37-8308-d0d3a2d8d7ab
Version: 9
Effective Time: 20231103
 
Chain Drugs Consortium, LLC