FLUTICASONE PROPIONATE spray, metered

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)
Available from:
Hi-Tech Pharmacal Co., Inc.
Administration route:
NASAL
Prescription type:
OTC DRUG
Therapeutic indications:
Allergy symptom reliever Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: ■ nasal congestion ■ runny nose ■ sneezing ■ itchy nose ■itchy, watery eyes
Authorization status:
Abbreviated New Drug Application
Authorization number:
50383-968-16, 50383-968-18, 50383-968-36, 50383-968-37, 50383-968-38

FLUTICASONE PROPIONATE- fluticasone propionate spray, metered

Hi-Tech Pharmacal Co., Inc.

----------

Drug Facts

Active ingredient

Fluticasone propionate (glucocorticoid) 50 mcg (in each spray)

Purpos e

Allergy symptom reliever

Keep Out of Reach of Children

Us es

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

Pregnancy 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

TAMPER EVIDENT: Do not use if plastic sleeve is torn or broken. Under the cap and nozzle, each

bottle has an aluminum seal around bottle neck. Do not use if any of these features are torn or

damaged.

■ you may start to feel relief the first day and full effect after several days of regular, once-a-day use

■ store between 4° and 30°C (39° and 86°F)

■ keep the label and enclosed materials. They contain important additional information.

Inactive Ingredients

benzalkonium chloride, carboxymethylcellulose sodium, dextrose, microcrystalline cellulose,

phenylethyl alcohol, polysorbate 80, and purified water

Questions or comments

Call toll-free 1-800-262-9010 weekdays (9:00 am- 5:00 pm)

What problems can Fluticasone Propionate Nasal Spray help with?

Fluticasone Propionate Nasal Spray helps relieve a broad range of uncomfortable symptoms like

congestion, runny nose, sneezing, itchy nose and itchy eyes.

These symptoms can be triggered by allergens like pollen, mold, dust and pet dander.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev.968:00 09/17

Package/Label Principal Display Panel

AKORN

* Compare to the active ingredient in Flonase

NDC 50383-968-16

Fluticasone Propionate Nasal Spray (Glucocorticoid), 50 mcg Per Spray

Allergy Symptom Reliever Nasal Spray

24 Hour Relief of:

Itchy, Watery Eyes

Nasal Congestion

Runny Nose

Itchy Nose

Sneezing

NEW: FULL PRESCRIPTION STRENGTH

NON DROWSY

24 HOUR RELIEF

120 METERED SPRAYS

0.54 fl oz (15.8 mL)

FLUTICASONE PROPIONATE

fluticasone propionate spray, metered

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 38 3-9 6 8

Route of Administration

NASAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FLUTICASO NE PRO PIO NATE (UNII: O2GMZ0 LF5W) (FLUTICASONE -

UNII:CUT2W21N7U)

FLUTICASONE

PROPIONATE

50 ug

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

DEXTRO SE, UNSPECIFIED FO RM (UNII: IY9 XDZ35W2)

PHENYLETHYL ALCO HO L (UNII: ML9 LGA746 8 )

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

Hi-Tech Pharmacal Co., Inc.

1

NDC:50 38 3-9 6 8 -

1 in 1 CARTON

0 4/18 /20 19

1

6 0 in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:50 38 3-9 6 8 -

1 in 1 CARTON

0 4/18 /20 19

2

120 in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:50 38 3-9 6 8 -

2 in 1 CARTON

0 4/18 /20 19

3

6 0 in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:50 38 3-9 6 8 -

2 in 1 CARTON

0 4/18 /20 19

4

120 in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

5

NDC:50 38 3-9 6 8 -

3 in 1 CARTON

0 4/18 /20 19

5

120 in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 8 0 24

0 4/18 /20 19

Labeler -

Hi-T ech Pharmacal Co., Inc. (117696873)

Registrant -

Akorn Operating Company LLC (117693100)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hi-Tech Pharmacal Co ., Inc.

1176 9 6 8 73

MANUFACTURE(50 38 3-9 6 8 )

Revised: 9/2020

Similar products

Search alerts related to this product

View documents history

Share this information