FDA Label for Fluticasone Propionate

Drug Facts

Active ingredient (in each spray)

Fluticasone propionate USP (glucocorticoid)^* 50 mcg

^*read the Question & Answer Leaflet

Purpose

Allergy symptom reliever

Uses

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

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

Warnings

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

FLUTICASONE PROPIONATE NASAL SPRAY, USP

QUICK START GUIDE

HOW TO START GETTING ALLERGY RELIEF RIGHT NOW

figure - fluticasone fig9

                                                                                               Children age 4 to 11

An adult should supervise use

Use one spray in each nostril once daily.

Don’t use more than one spray in each nostril per day.

If you miss a dose, just use your regular dose the next day. Don’t add an extra dose.

Check with a doctor if a child needs to use Fluticasone Propionate Nasal Spray, USP for longer than two months a year.

                                                                                                  Users age 12 or older

In your first week

Use two sprays in each nostril every day.

Don’t use more than two sprays in each nostril per day.

After your first week

If your symptoms are under control, you may reduce to one spray in each nostril every day. If your symptoms get worse, go back to two sprays in each nostril.

If you miss a dose, just use your regular dose the next day. Don’t add an extra dose.

WARNING: Do not spray in your eyes. Only for use in your nose.

KEEP IT CLEAN

A clean spray nozzle helps ensure a full dose. Clean it weekly, or if it’s clogged. Don’t try to unblock nozzle with pin or sharp object – that can damage it.

Remove spray nozzle by grasping at base and pulling up.

Rinse under running tap, and dry at  room temperature.

Aim away from your face and gently replace spray nozzle until you hear a soft click.

If spray nozzle is clogged, soak in warm water. Then repeat steps 2 and 3.

GET THE RELIEF YOU NEED.

Fluticasone Propionate Nasal Spray, USP can relieve your allergy symptoms. For best results, it’s important to get a full dose. Here’s how, in five easy steps.

1  Shake

Gently shake spray bottle.

Remove translucent cap.

2  Prime

Do this when:

• Starting new bottle
• Haven’t used it in a week
• Just cleaned nozzle

Otherwise go to Step 3.

Aim away from face. Grasp spray bottle as shown. Pump until fine mist appears.

Pumped six times and still no mist? Spray nozzle may be clogged. See KEEP IT CLEAN.

3  Blow

Blow nose gently to clear nostrils.

4  Aim

Close one nostril and put tip of spray nozzle in other nostril.

Put just the tip into your nose.

Aim slightly away from center of nose.

5  Breathe and Spray

While sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). You’ll feel a light mist in your nose. Breathe out through your mouth.

Repeat in other nostril.

Wipe spray nozzle with clean tissue and replace cap.

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

Revised: 04/2024

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 between 4° and 30°C (39° and 86°F)
• keep this carton and enclosed materials. They contain important additional information.

Inactive Ingredients

benzalkonium chloride, dextrose anhydrous, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol, polysorbate 80, and purified water

Questions Or Comments?

call 1-855-274-4122  (Monday – Friday 8:30 AM to 5:00 PM EST)

Other

Is Fluticasone Propionate Nasal Spray, USP OK to use with other medicines?

You should tell your doctor about all the medicines you take, including Fluticasone Propionate Nasal Spray, USP. Fluticasone Propionate Nasal Spray, USP can be used with most non-prescription and prescription medicines. However, there are a few medicines to look out for because they may cause the level of Fluticasone Propionate Nasal Spray, USP in your body to become too high. Just to be safe, check this table to see if you’re taking any of these medicines.

Figure 8 - fluticasone fig8

What To Expect

What it’s like to use Fluticasone Propionate Nasal Spray, USP.

How soon will I get relief?

You may start to feel relief the first day you use Fluticasone Propionate Nasal Spray, USP. Keep using it every day, though. It takes several days before Fluticasone Propionate Nasal Spray, USP builds up to full effectiveness.

How long will the relief last?

Fluticasone Propionate Nasal Spray, USP is meant to control your symptoms every day, all day and all night. To help you get this lasting relief, it’s important to use Fluticasone Propionate Nasal Spray, USP regularly, once a day.

Does Fluticasone Propionate Nasal Spray, USP cause a "rebound" effect?

No, Fluticasone Propionate Nasal Spray, USP does not cause a rebound effect.

Some nasal decongestant sprays may cause your nasal passages to swell up even more when you use them too often or for longer than their label says you should (three days). This is sometimes called a “rebound effect.”

Fluticasone Propionate Nasal Spray, USP is a different kind of medicine and does not cause any rebound effect. You can use Fluticasone Propionate Nasal Spray, USP for up to six months if you are age 12 or older or up to two months a year if you are age 4 to 11 before checking with a doctor.

Will Fluticasone Propionate Nasal Spray, USP make me drowsy?

No, Fluticasone Propionate Nasal Spray, USP does not cause drowsiness. Some allergy medications can cause drowsiness, but Fluticasone Propionate Nasal Spray, USP does not.

Why does Fluticasone Propionate Nasal Spray, USP have a smell?

The light floral scent you may notice comes from one of the important ingredients in the Fluticasone Propionate Nasal Spray, USP formula. No fragrance is added to Fluticasone Propionate Nasal Spray, USP.

What if little or nothing is spraying out?

Try priming the spray bottle. It may take a few pumps to get the dispenser spraying again. If that doesn’t work, the spray nozzle may be clogged.

You can clean it following the directions in the Quick Start Guide on the other side.

What if I feel stinging in my nose, or I sneeze?

Some people may feel a slight stinging, or may sneeze, after spraying Fluticasone Propionate Nasal Spray, USP in their nostrils. This feeling should go away in a few seconds.

What if I feel or taste the medicine in my throat?

Generally, you can avoid this by taking a shallower breath next time you spray Fluticasone Propionate Nasal Spray, USP into your nostrils. For example, take the kind of breath you would use to smell a flower.

What if I have chicken pox, measles or tuberculosis or come into contact with someone who does?

Stop using Fluticasone Propionate Nasal Spray, USP and ask your doctor.

What if I’m having severe sinus pain?

If you feel severe pain in your face, have thick nasal discharge, or think you may have a sinus infection, stop using Fluticasone Propionate Nasal Spray, USP and see your doctor. Your doctor may want to consider if other medicines are needed.

What if my symptoms aren’t better after one week?

If you have used Fluticasone Propionate Nasal Spray, USP for a week and your allergy symptoms are not getting better, stop use and ask your doctor. You may have an infection.

Does Fluticasone Propionate Nasal Spray, USP have side effects?

Serious side effects are rare with Fluticasone Propionate Nasal Spray, USP because Fluticasone Propionate Nasal Spray, USP works in your nose, and barely any of it travels through your body. However, like all medicines, Fluticasone Propionate Nasal Spray, USP can cause side effects in some people.

Here are some side effects that have been reported when using Fluticasone Propionate Nasal Spray, USP. If you have any concerns about side effects, talk with your doctor.

STILL HAVE QUESTIONS? Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

Revised: 04/2024

Package Label.Principal Display Panel - 50 Mcg Per Spray (120 Metered Sprays, Bottle Label)

NDC 58602-017-43

Fluticasone Propionate
Nasal Spray, USP
(Glucocorticoid)
50 mcg per spray

Allergy Symptom Reliever

120 Metered Sprays    0.54 fl oz (15.8 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 50 mcg per spray (60 Metered Sprays, Bottle Label) - fluticasone fig27

Package Label.Principal Display Panel - 50 Mcg Per Spray (120 Metered Sprays, Carton Label)

NDC 58602-017-43

#Compare to the active ingredient in Flonase^® Allergy Relief

NON-DROWSY

Fluticasone Propionate
Nasal Spray, USP
(Glucocorticoid)*
50 mcg per spray

Allergy Symptom Reliever

Relief of:

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

FULL PRESCRIPTION STRENGTH

24 Hour relief

*Fluticasone propionate is a steroid
medicine known as a glucocorticoid.

120 Metered Sprays
0.54 fl oz (15.8 mL)




figure - fluticasone fig28