Label: FLUTICASONE PROPIONATE spray, metered
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NDC Code(s):
50383-968-16,
50383-968-18,
50383-968-36,
50383-968-37, view more50383-968-38
- Packager: Akorn
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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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 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
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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
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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
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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
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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)
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INGREDIENTS AND APPEARANCE
FLUTICASONE PROPIONATE
fluticasone propionate spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50383-968 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE PROPIONATE 50 ug Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50383-968-18 1 in 1 CARTON 04/18/2019 1 60 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:50383-968-16 1 in 1 CARTON 04/18/2019 2 120 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:50383-968-36 2 in 1 CARTON 04/18/2019 3 60 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 4 NDC:50383-968-37 2 in 1 CARTON 04/18/2019 4 120 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 5 NDC:50383-968-38 3 in 1 CARTON 04/18/2019 5 120 in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208024 04/18/2019 Labeler - Akorn (117696873) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn 117696873 MANUFACTURE(50383-968)
