Fluticasone Propionate by Topco Associates LLC
Medically reviewed on December 21, 2017
Dosage form: spray, metered
Ingredients: FLUTICASONE PROPIONATE 50ug
Labeler: Topco Associates LLC
NDC Code: 36800-028
Fluticasone propionate (glucocorticoid) 50 mcg.
Allergy symptom reliever
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
• nasal congestion • runny nose • sneezing • itchy nose
Only for use in the nose. Do not spray into your eyes or mouth.
- 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
- medicine for HIV infection (such as ritonavir)
- a steroid medicine for asthma, allergies or skin rash
- ketoconazole pills (medicine for fungal infection)
- 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
- 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.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- 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.
0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water
call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time
CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray
TOPCO NDC 36800-028-01
Fluticasone Propionate Nasal Spray, USP
Allergy Symptom Reliever Nasal Spray
24 Hour Relief of:
- Nasal Congestion
- Runny Nose
- Itchy Nose
fluticasone propionate spray, metered
|Labeler - Topco Associates LLC (006935977)|
|Registrant - Apotex Inc. (209429182)|
|Apotex Inc.||255092496||analysis(36800-028), manufacture(36800-028)|
|Legacy Pharmaceutical Packaging||143213275||pack(36800-028)|
|Bellwyck Packaging Solution||203021662||pack(36800-028)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.