Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID cee73f84-40fb-7143-0f11-4d119de6a905
Route
NASAL
Published
Effective Date 2021-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluticasone (50 ug)
Inactive Ingredients
Benzalkonium Chloride Carboxymethylcellulose Sodium, Unspecified Microcrystalline Cellulose Dextrose, Unspecified Form Phenylethyl Alcohol Polysorbate 80 Water

Identifiers & Packaging

Marketing Status
ANDA Completed Since 2021-03-11 Until 2026-08-31

Description

Fluticasone propionate (glucocorticoid) 50 mcg.

Purpose

Allergy symptom reliever


Medication Information

Purpose

Allergy symptom reliever

Description

Fluticasone propionate (glucocorticoid) 50 mcg.

Use

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

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

Section 50569-3

Ask a doctor before use if you  have or had glaucoma or cataracts

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

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

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

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
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

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
Keep Out of Reach of Children.

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

Active Ingredient (in Each Spray)

Fluticasone propionate (glucocorticoid) 50 mcg.

Principal Display Panel Bottle 72md

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL

Target Corporation

NDC 11673-262-05

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

50 mcg per spray

72 sprays

Allergy Symptom Reliever Nasal Spray

Principal Display Panel Carton 72md

CARTON LABEL - PRINCIPAL DISPLAY PANEL

Target Corporation

NDC 11673-262-04

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

72 metered sprays 

50 mcg per spray

­ Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

Principal Display Panel Bottle 144md

Target Corporation

NDC 11673-262-02

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

50 mcg per spray

72 sprays

Allergy Symptom Reliever Nasal Spray

Principal Display Panel Carton 144md

CARTON LABEL - PRINCIPAL DISPLAY PANEL

Target Corporation

NDC 11673-262-01

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

144 metered sprays 

50 mcg per spray ­ 

Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

Principal Display Panel Carton 2x144md

CARTON LABEL - PRINCIPAL DISPLAY PANEL

Target Corporation

NDC 11673-262-03

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

2 x 144 metered sprays 

50 mcg per spray  ­ 

Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

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)

Structured Label Content

Use

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

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

Section 50569-3 (50569-3)

Ask a doctor before use if you  have or had glaucoma or cataracts

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Allergy symptom reliever

Warnings

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

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

Do Not Use (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
Other Information (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 (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? (Questions or comments?)

call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time

When Using This Product (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 (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
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Spray) (Active ingredient (in each spray))

Fluticasone propionate (glucocorticoid) 50 mcg.

Principal Display Panel Bottle 72md (Principal Display Panel - Bottle 72md)

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL

Target Corporation

NDC 11673-262-05

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

50 mcg per spray

72 sprays

Allergy Symptom Reliever Nasal Spray

Principal Display Panel Carton 72md (Principal Display Panel - Carton 72md)

CARTON LABEL - PRINCIPAL DISPLAY PANEL

Target Corporation

NDC 11673-262-04

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

72 metered sprays 

50 mcg per spray

­ Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

Principal Display Panel Bottle 144md (Principal Display Panel - Bottle 144md)

Target Corporation

NDC 11673-262-02

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

50 mcg per spray

72 sprays

Allergy Symptom Reliever Nasal Spray

Principal Display Panel Carton 144md (Principal Display Panel - Carton 144md)

CARTON LABEL - PRINCIPAL DISPLAY PANEL

Target Corporation

NDC 11673-262-01

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

144 metered sprays 

50 mcg per spray ­ 

Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

Principal Display Panel Carton 2x144md (Principal Display Panel - Carton 2x144md)

CARTON LABEL - PRINCIPAL DISPLAY PANEL

Target Corporation

NDC 11673-262-03

Allergy Relief Nasal Spray

Fluticasone Propionate Nasal Spray, USP ­

2 x 144 metered sprays 

50 mcg per spray  ­ 

Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

Ask A Doctor Or Pharmacist Before Use If You Are Taking (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)

Advanced Ingredient Data


Raw Label Data

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