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Fluticasone Propionate by Freds Inc

Dosage form: spray, metered
Ingredients: FLUTICASONE PROPIONATE 50ug
Labeler: Freds Inc
NDC Code: 55315-825

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

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
  • read the Quick Start Guide for how to:
    •  prime the bottle
    • use the spray
    • clean the spray nozzle
  • shake gently before each use
  • use this product only once a day
  • do not use more than directed

    ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

  • Week 1 - use 2 sprays in each nostril once daily

  • Week 2 through 6 months - use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms

  • After 6 months of daily use - ask your doctor if you can keep using

    CHILDREN 4 TO 11 YEARS OF AGE

  •  the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child's doctor if your child needs to use the spray for longer than two months a year.

  • an adult should supervise use

  • use 1 spray in each nostril once daily

    CHILDREN UNDER 4 YEARS OF AGE

  • do not use

Other information
  • you may start to feel relief the first day and full effect after several days of regular, once-a-day use
  •  store at 4° to 30°C (39° to 86°F)
  • keep this label and enclosed materials. They contain important additional 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

Fred's, Inc. NDC 55315-825-60

Fluticasone Propionate Nasal Spray, USP ­

60 sprays

Allergy Symptom Reliever Nasal Spray

Principal Display Panel - Bottle 120ms

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Fred's Inc. NDC 55315-825-12

Fluticasone Propionate Nasal Spray, USP

120 sprays

Allergy Symptom Reliever Nasal Spray

Principal Display Panel - Carton 60ms

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray 

Fred's, Inc. NDC 53315-825-60

Fluticasone Propionate Nasal Spray, USP ­

60 sprays 

­Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

Principal Display Panel - Carton 120ms

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray 

Fred's, Inc. NDC 55315-825-12

Fluticasone Propionate Nasal Spray, USP ­

120 sprays ­

Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

FLUTICASONE PROPIONATE 
fluticasone propionate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-825
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE PROPIONATE (Fluticasone) FLUTICASONE PROPIONATE50 ug
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
DEXTROSE 
PHENYLETHYL ALCOHOL 
POLYSORBATE 80 
WATER 
Packaging
#Item CodePackage Description
1NDC:55315-825-601 BOTTLE, SPRAY in 1 CARTON
160 SPRAY, METERED in 1 BOTTLE, SPRAY
2NDC:55315-825-121 BOTTLE, SPRAY in 1 CARTON
2120 SPRAY, METERED in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20815011/28/2016
Labeler - Freds Inc (005866116)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIOperations
Apotex Inc.255092496analysis(55315-825), manufacture(55315-825)
Establishment
NameAddressID/FEIOperations
Legacy Pharmaceutical Packaging143213275pack(55315-825)

 
Freds Inc

← See all Fluticasone Propionate brands

Medically reviewed on Dec 21, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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