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NDC 68196-0208-00 Fluticasone Propionate 50 ug/1 Details

Fluticasone Propionate 50 ug/1

Fluticasone Propionate is a NASAL SPRAY, METERED in the HUMAN OTC DRUG category. It is labeled and distributed by Sam's West Inc.. The primary component is FLUTICASONE PROPIONATE.

MedlinePlus Drug Summary

Nonprescription fluticasone nasal spray (Flonase Allergy) is used to relieve symptoms of rhinitis such as sneezing and a runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Prescription fluticasone is also used to relieve symptoms of nonallergic rhinitis such as sneezing and runny or stuffy nose which are not caused by allergies. Prescription fluticasone nasal spray (Xhance) is used to treat nasal polyps (swelling of the lining of the nose). Fluticasone nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold. Fluticasone is in a class of medications called corticosteroids. It works by blocking the release of certain natural substances that cause allergy symptoms.

Related Packages: 68196-0208-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluticasone Nasal Spray

Product Information

NDC	68196-0208
Product ID	68196-208_11bef410-0a4c-a975-904b-43439f12bd88
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Fluticasone Propionate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Fluticasone Propionate
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY, METERED
Route	NASAL
Active Ingredient Strength	50
Active Ingredient Units	ug/1
Substance Name	FLUTICASONE PROPIONATE
Labeler Name	Sam's West Inc.
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208150
Listing Certified Through	n/a

Package

Package Images

NDC 68196-0208-00 (68196020800)

Pricing Information	N/A
NDC Package Code	68196-208-00
Billing NDC	68196020800
Package	120 SPRAY, METERED in 1 BOTTLE, SPRAY (68196-208-00)
Marketing Start Date	2019-11-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1855acae-b4eb-86e8-c7de-f668837734af Details

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

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 - Carton

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Aller-Nose Nasal Spray

Fluticasone Propionate Nasal Spray, USP

Apotex Corp. NDC 68196-208-01

6 bottles (120 sprayseach)

Allergy Symptom Reliever Nasal Spray

24 Hour Relief of:

Itchy, Watery Eyes
Nasal Congestion
Runny Nose
Itchy Nose
Sneezing

Principal Display Panel - Bottle

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray