FLONASE

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active Ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Fluticasone propionate (glucocorticold) 50 mcg

Purpose

OTC - PURPOSE SECTION

Allergy symptom reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

• nasal congestion
• runny nose
• sneezing
• itchy nose
• itchy, watery eyes

Warnings

WARNINGS SECTION

Only for use in the nose. Do not spray into your eyes or mouth.

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

have or had glaucoma or cataracts

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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 this label and enclosed materials. They contain important additional information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethylalcohol, polysorbate 80, purified water, sodium carboxymethylcellulose

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-844-FLONASE (1-844-356-6273) (English/Spanish) weekdays

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1978

NDC: 50090-1978-0 120 SPRAY, METERED in a BOTTLE / 1 in a PACKAGE

fluticasone propionate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

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FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

• FLONASE ALLERGY RELIEF
• fluticasone propionate
• FLUTICASONE
• BENZALKONIUM CHLORIDE
• DEXTROSE, UNSPECIFIED FORM
• MICROCRYSTALLINE CELLULOSE
• PHENYLETHYL ALCOHOL
• POLYSORBATE 80
• WATER
• CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.