Active Ingredient (In Each Spray)
Fluticasone propionate (glucocorticoid) *50 mcg.
*read the Question & Answer Leaflet
The following Structured Product Label (SPL) was submitted to the FDA by Sam's West, Inc for the product Fluticasone Propionate (NDC 68196-503). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each spray), purpose, uses, warnings, do not use, ask a doctor or pharmacist before use if you are taking, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Fluticasone propionate (glucocorticoid) *50 mcg.
*read the Question & Answer Leaflet
Allergy symptom reliever
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
• nasal congestion • itchy nose • runny nose • itchy, watery eyes • sneezing
Only for use in the nose. Do not spray into your eyes or mouth.
In case of overdose, get medical help or contact a Poison Control Center right away.
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
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
Aller-Nose Nasal Spray
Fluticasone Propionate Nasal Spray, USP
Apotex Corp. NDC 68196-503-01
6 bottles (144 sprays each)
Allergy Symptom Reliever Nasal Spray
24 Hour Relief of:
* Please review the disclaimer below.