Topcare nasoflow allergy relief spray, metered

Active ingredient (in each spray)

Fluticasone propionate (glucocorticoid) 50 mcg

Purpose

Allergy symptom reliever

Uses

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

  • nasal congestion
  • runny nose
  • sneezing
  • itchy nose

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

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 (1-800-222-1222).

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 childs 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 oand 30 oC (39 oand 86 oF)
  • keep this package and enclosed materials. They contain important additional information.

Inactive ingredients

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

Questions or comments?

1-888-423-0139

Consumer information

FLUTICASONE PROPIONATE NASAL SPRAY QUESTIONS & ANSWERS

WHAT FLUTICASONE PROPIONATE NASAL SPRAY IS, HOW TO USE IT, AND WHAT TO EXPECT.

UNDERSTANDING FLUTICASONE PROPIONATE NASAL SPRAY

What Fluticasone Propionate Nasal Spray is, and how it works.

What is Fluticasone Propionate Nasal Spray?

Fluticasone Propionate Nasal Spray is an effective, allergy medicinethat you can now buy without a prescription. It works directly in the nose to help block your allergic reactions. Fluticasone Propionate Nasal Spray relieves allergy symptoms caused by pollen, mold, dust and pets.

What is the active ingredient in Fluticasone Propionate Nasal Spray?

The active ingredient in Fluticasone Propionate Nasal Spray is called fluticasone propionate.Fluticasone propionate is a glucocorticoid a substance produced naturally by your body to help fight inflammation. It works in your nose to relieve your allergy symptoms. Barely any of it travels through your body. Its been prescribed by doctors for over 20 years, and used effectively by millions.

A glucocorticoid is a kind of steroid that is different from the anabolic (muscle-building) steroids sometimes misused by athletes. In fact, world class athletes are allowed to use glucocorticoids during competition to treat their allergies.

Who should not use Fluticasone Propionate Nasal Spray?

For complete guidance, check the Drug Facts label on the back of the Fluticasone Propionate Nasal Spray package.

Can I use Fluticasone Propionate Nasal Spray for asthma?

No, Fluticasone Propionate Nasal Spray is not a treatment for asthma.Ask your doctor what medicine to take for your asthma.

Can I use Fluticasone Propionate Nasal Spray for colds?

No, use Fluticasone Propionate Nasal Spray to treat only your allergiesnot your cold symptoms. If youre not sure whether your symptoms come from allergies or a cold, ask your doctor.

What happens when you have allergies?

Allergies start whenallergens like pollen or pet dander enter your body and trigger your immune system to respond.

Your bodys natural responseis to release multiple inflammatory substances, (also referred to as mediators) that cause your allergy symptoms.

Fluticasone Propionate Nasal Spray Image 1

How does Fluticasone Propionate Nasal Spray work?

Fluticasone Propionate Nasal Spray works right in your noseto help block your allergic reaction at the source to relieve the symptoms that make you uncomfortable.

Fluticasone Propionate Nasal Sprayacts on multiple inflammatory substances, including histamine, prostaglandins, cytokines, tryptases, chemokines and leukotrienes.

Fluticasone Propionate Nasal Spray Image 2

Most common OTC allergy pills act on histamine alone.

Because of the way it works, it may take several days for Fluticasone Propionate Nasal Spray to reach maximum effect. Thats why its best to use Fluticasone Propionate Nasal Spray regularly, once a day.

Fluticasone Propionate Nasal Spray not only relieves sneezing, itchy nose, and runny nose, but also relieves nasal congestion.

Who should not use Fluticasone Propionate Nasal Spray or check with a doctor first?

Some people should not use Fluticasone Propionate Nasal Spray, or need to check with a health professional first. This table offers a quick summary of these situations.

If you

Heres what to do

Are younger than 4

Do not use Fluticasone Propionate Nasal Spray

Are pregnant or breast-feeding

Talk to a health professional before using Fluticasone Propionate Nasal Spray

Have or had glaucoma or cataracts

Talk to your doctor before using Fluticasone Propionate Nasal Spray

Have an injury or surgery to your nosethat is not fully healed

Do not use Fluticasone Propionate Nasal Spray

Have ever had an allergic reactionto Fluticasone Propionate Nasal Spray or any of its ingredients

Do not use Fluticasone Propionate Nasal Spray

Are taking medicine for HIV infection (such as ritonavir)

Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray

Are taking ketoconazole pills(medicine for fungal infection)

Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray

Are using a steroid medicine for asthma, allergies, skin rash, allergic reactions, inflammation or eye conditions

Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray

What problems can Fluticasone Propionate Nasal Spray help with?

Allergies can cause uncomfortable symptoms like congestion. These symptoms can be triggered by allergens like pollen, mold, dust or pet dander.

Fluticasone Propionate Nasal Spray helps relieve a broad range of symptomsfrom many allergens. For example, Fluticasone Propionate Nasal Spray helps with:

Fluticasone Propionate Nasal Spray Image 3

USING FLUTICASONE PROPIONATE NASAL SPRAY

How to get the best results with Fluticasone Propionate Nasal Spray.

Read the Drug Facts label on the back of the package or the Quick Start Guide on the other side for simple directions on using Fluticasone Propionate Nasal Spray.

Watch for purple color - it shows where there is different information for children ages 4-11, compared to users age 12 or older.

If you still have questions about using Fluticasone Propionate Nasal Spray after reading the Quick Start Guide, read this section for answers.

I know how to use a nasal spray. Why do I have to follow the directions?

If you dont use the spray bottle correctly, you might not get a full dose.Without a full dose each time, you might not get the relief you deserve.

Follow the simple directions in the Quick Start Guideon other side.

If my symptoms go away, should I stop using Fluticasone Propionate Nasal Spray?

You may be tempted to stop using Fluticasone Propionate Nasal Spray when you start to feel better. Its important you keep using Fluticasone Propionate Nasal Spray daily as long as youre exposed to allergensthat bother you, like pollen, mold, dust or pet dander. This way youll keep feeling relief.

If you suffer allergy symptoms only during certain times, like when pollen levels are high, you may stop using Fluticasone Propionate Nasal Spray when that time ends. If you are age 12 or older and need to use daily for longer than 6 months or age 4-11 and need to use for longer than 2 months a year, check with your doctor.

What if I miss a dose by accident?

If you miss a dose, just use your regular dose the next day.Dont add an extra dose to make up for it.

Can I keep using Fluticasone Propionate Nasal Spray year round?

Some people suffer from allergies all year. If you are age 12 or older and have used Fluticasone Propionate Nasal Spray for six months or age 4-11 and have used for two months a year, check with your doctor to make sure its OK to keep using Fluticasone Propionate Nasal Spray. In fact, its a good idea for anyone with persistent allergies to talk with a doctor every so often about symptoms and medicines.

Can I share my Fluticasone Propionate Nasal Spray?

Do not share a bottle of Fluticasone Propionate Nasal Spray.Sharing the bottle can spread germs, because you insert the nozzle in your nose.

Can I spray Fluticasone Propionate Nasal Spray in my eyes or mouth?

No, Fluticasone Propionate Nasal Spray is meant to work only in your noseto relieve your allergy symptoms.

Never spray Fluticasone Propionate Nasal Spray in your eyes or your mouth.

Fluticasone Propionate Nasal Spray Image 4

Some decongestants may increase blood pressure. Does Fluticasone Propionate Nasal Spray increase blood pressure?

When used as directed, Fluticasone Propionate Nasal Spray does not increase blood pressure.

Wont I waste product by priming?

Its not a waste to prime the pump, because it helps you get a full dose.Getting a full dose is important for getting the relief you deserve. See the Quick Start Guide for when and how to prime the pump.

Dont worry about running out due to priming.There is enough medicine in the spray bottle to allow for priming sprays plus the number of sprays labeled on the bottle.

Always point the spray bottle away from your facewhen priming.

How long should a bottle of Fluticasone Propionate Nasal Spray last?

This table shows roughly how long your bottle will last.It assumes you follow the instructions for priming the pump, and that those age 12 or older use two sprays in each nostril every day while children age 4-11 use one spray in each nostril every day.

After youve used the number of sprays shown on the label, each spray may not deliver a full dose even if there is liquid left in the bottle.

If the label says

The bottle should last age 12+

The bottle should last age 4-11

30 sprays

1 week

2 weeks

60 sprays

2 weeks

4 weeks

120 sprays

4 weeks

8 weeks

150 sprays

5 weeks

10 weeks*

*Check with a doctor if a child 4-11 needs to use longer than 2 months a year

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

You should tell your doctor about all the medicines you take, including Fluticasone Propionate Nasal Spray. Fluticasone Propionate Nasal Spray 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 in your body to become too high.

Just to be safe, check this tableto see if youre taking any of these medicines.

If youre taking

Heres what to do

Medicines for HIV infection (such as ritonavir)

Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray

Medicines with glucocorticoidsIncluding some medicines for skin rash such as eczema, asthma, inflammation, allergic reactions, or eye conditions

Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray

KetoconazolePills for fungal infection

Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray

What are the differences in the way children age 4-11 should use Fluticasone Propionate Nasal Spray?

Children age 4-11 should use a lower doseof Fluticasone Propionate Nasal Spray for a shorter period of time.

Ages

Children 4-11 years of age

Users 12 years of age and older

Dosage

1 spray in each nostril once daily

Up to 2 sprays in each nostril once daily

Duration before checking with a doctor

Up to 2 months of use a year

Up to 6 months of daily use

Why is the use of Fluticasone Propionate Nasal Spray for children age 4-11 limited to 2 months a year before checking with a doctor?

When used long-term, intranasal glucocorticoids like Fluticasone Propionate Nasal Spray may cause the growth rate of some children to be slower. Whether this will affect a childs ultimate height is not known. As a precaution, children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your childs doctor if your child needs to use the spray for longer than 2 months a year.

WHAT TO EXPECT

What its like to use Fluticasone Propionate Nasal Spray.

How soon will I get relief?

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

How long will the relief last?

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

Does Fluticasone Propionate Nasal Spray cause a rebound effect?

No, Fluticasone Propionate Nasal Spray 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 is a different kind of medicine and does not cause any rebound effect. You can use Fluticasone Propionate Nasal Spray for up to six months if you are age 12 or older or up to two months a year if you are age 4-11 before checking with a doctor.

Will Fluticasone Propionate Nasal Spray make me drowsy?

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

Why does Fluticasone Propionate Nasal Spray have a smell?

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

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 doesnt 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 in their nostrils. This feeling should go awayin a few seconds.

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

Generally, you can avoid this by taking a shallower breathnext time you spray Fluticasone Propionate Nasal Spray 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 and ask your doctor.

What if Im 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 and see your doctor.Your doctor may want to consider if other medicines are needed.

What if my symptoms arent better after one week?

If you have used Fluticasone Propionate Nasal Spray 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 have side effects?

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

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

Sudden swelling of face or tongue
  • A rash
  • Wheezing or feeling faintSevere or frequent nosebleedsConstant whistling sound that does not go awayCloudy vision
  • Reduced visionSlower growth rate in some children while using productHeadaches or sneezing
  • Bad taste or smell
  • Minor nosebleeds
  • Dry or irritated nose or throat.

    Side effect

    What could happen

    What to do

    Allergic reaction to the product

    If you feel any of these symptoms, stop using Fluticasone Propionate Nasal Spray and see a doctor right away.

    Nose injury

    Apply pressure to your nose. Stop using Fluticasone Propionate Nasal Spray and see a doctor.

    This could be a sign of damage to your nose. Stop using Fluticasone Propionate Nasal Spray and see a doctor right away.

    Eye conditionssuch as cataracts or glaucoma

    Have a yearly eye exam to check for these conditions. Read the Drug Factson the back of the Fluticasone Propionate Nasal Spray package for more details.

    Growth effects

    Talk to your doctor if you are concerned or if a child age 4-11 needs to use Fluticasone Propionate Nasal Spray for longer than two months a year.

    Other side effects

    Talk to your doctor or pharmacist if you are concerned.

    STILL HAVE QUESTIONS?Call 1-800-719-9260

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    FLUTICASONE PROPIONATE NASAL SPRAY

    QUICK START GUIDE

    HOW TO START GETTING ALLERGY RELIEF RIGHT NOW

    USE THE RIGHT DOSE

    Fluticasone Propionate Nasal Spray works best when you use it daily. Heres how to get started.

    Children age 4-11

    An adult should supervise use

    Use one spray in each nostril once daily.

    Fluticasone Propionate Nasal Spray Image 5

    Dont use more than one spray in each nostril per day.

    If you miss a dose,just use your regular dose the next day. Dont add an extra dose.

    Check with a doctorif a child needs to use Fluticasone Propionate Nasal Spray for longer than two months a year.

    Users age 12 or older

    In your first week

    Use two sprays in each nostril every day.

    Fluticasone Propionate Nasal Spray Image 6

    Dont 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. Dont add an extra dose.

    Fluticasone Propionate Nasal Spray Image 7

    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 its clogged. Dont try to unblock nozzle with pin or sharp object that can damage it.

    Bottle Directions

    Remove spray nozzle by grasping at base and pulling up.

    Bottle Image

    Rinse under running tap, and dry at room temperature.

    Bottle Image

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

    Bottle Directions

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

    GET THE RELIEF YOU NEED.

    Fluticasone Propionate Nasal Spray can relieve your allergy symptoms. For best results, its important to get a full dose.

    Heres how, in five easy steps.

    Shake

    Gently shake spray bottle.

    Bottle Cap

    Remove clear cap.

    Prime

    Do this when:

    Starting new bottle

    Havent 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.

    Blow

    Blow nose gently to clear nostrils.

    Aim

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

    Bottle Image

    Put just the tip into your nose.

    Mist

    Aim slightly away from center of nose.

    Spray

    While sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). Youll 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.

    Ingredients and appearance - Product information

    Topcare nasoflow allergy relief spray, metered- Fluticasone propionate

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 36800-315
    Route of Administration Nasal

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Fluticasone propionate ( UNII: O2GMZ0LF5W)( Fluticasone - UNII: CUT2W21N7U ) 50 ugin 1

    Inactive Ingredients

    Ingredient Name Code
    Benzalkonium chloride ( UNII: F5UM2KM3W7)
    Dextrose ( UNII: IY9XDZ35W2)
    Microcrystalline cellulose ( UNII: OP1R32D61U)
    Phenylethyl alcohol ( UNII: ML9LGA7468)
    Polysorbate 80 ( UNII: 6OZP39ZG8H)
    Water ( UNII: 059QF0KO0R)
    Carboxymethylcellulose sodium ( UNII: K679OBS311)

    Product Characteristics

    Color WHITE (off-white)

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    ANDA ANDA207957 USA

    Labeler - Topco Associates LLC( 006935977)

    Package/label principal display panel

    24 HOUR RELIEF

    Full Prescription Strength

    Nasoflow™ Allergy Relief

    FLUTICASONE PROPIONATE

    (GLUCOCORTICOID) 50 mcg PER SPRAY

    ALLERGY SYMPTOM RELIEVER

    NASAL SPRAY

    24 Hour Relief of:

    Nasal Congestion

    Runny Nose

    Itchy Nose

    Sneezing

    Non-Drowsy

    COMPARE TO FLONASE® ALLERGY RELIEF active ingredient

    120 METERED SPRAYS

    0.54 FL OZ (15.8 mL)