DOSAGE & ADMINISTRATION SECTION.


Directions. oread the Quick Start Guide for how to:oprime the bottleouse the sprayoclean the spray nozzleoshake gently before each useouse this product only once dayodo not use more than directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERoWeek - use sprays in each nostril once dailyoWeek through months use or sprays in each nostril once daily, as needed to treat your symptomsoAfter months of daily use ask your doctor if you can keep usingCHILDREN TO 11 YEARS OF AGEothe 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 year.oan adult should supervise useouse spray in each nostril once dailyCHILDREN UNDER YEARS OF AGEodo not use. oread the Quick Start Guide for how to:. oprime the bottle. ouse the spray. oclean the spray nozzle. oshake gently before each use. ouse this product only once day. odo not use more than directed. oWeek - use sprays in each nostril once daily. oWeek through months use or sprays in each nostril once daily, as needed to treat your symptoms. oAfter months of daily use ask your doctor if you can keep using. othe 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 year.. oan adult should supervise use. ouse spray in each nostril once daily. odo not use. Other information. oyou may start to feel relief the first day and full effect after several days of regular, once-a-day useostore between and 30C (39 and 86F) okeep this package and enclosed materials. They contain important additional information.. oyou may start to feel relief the first day and full effect after several days of regular, once-a-day use. ostore between and 30C (39 and 86F) okeep this package and enclosed materials. They contain important additional information.

INULLCTIVE INGREDIENT SECTION.


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

INDICATIONS & USAGE SECTION.


Uses. Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: onasal congestion orunny nose osneezing oitchy nose oitchy, watery eyes onasal congestion orunny nose osneezing oitchy nose oitchy, watery eyes.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient (in each spray). Fluticasone propionate (glucocorticoid) 50 mcg.

OTC - ASK DOCTOR SECTION.


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

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are taking. omedicine for HIV infection (such as ritonavir) oa steroid medicine for asthma, allergies or skin rashoketoconazole pills (medicine for fungal infection) omedicine for HIV infection (such as ritonavir) oa steroid medicine for asthma, allergies or skin rash. oketoconazole pills (medicine for fungal infection).

OTC - DO NOT USE SECTION.


Do not use. oin children under years of ageoto treat asthmaoif you have an injury or surgery to your nose that is not fully healedoif you have ever had an allergic reaction to this product or any of the ingredients. oin children under years of age. oto treat asthma. oif you have an injury or surgery to your nose that is not fully healed. oif you have ever had an allergic reaction to this product or any of the ingredients.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).

OTC - PREGNULLNCY OR BREAST FEEDING SECTION.


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

OTC - PURPOSE SECTION.


Purpose. Allergy symptom reliever.

OTC - QUESTIONS SECTION.


Questions or comments. 1-800-719-9260.

OTC - STOP USE SECTION.


Stop use and ask doctor if. oyou have, or come into contact with someone who has, chicken pox, measles or tuberculosisoyour symptoms do not get better within 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. oyou get constant whistling sound from your nose. This may be sign of damage inside your nose.oyou get an allergic reaction to this product. Seek medical help right away.oyou get new changes to your vision that develop after starting this productoyou have severe or frequent nosebleeds oyou have, or come into contact with someone who has, chicken pox, measles or tuberculosis. oyour symptoms do not get better within 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. oyou get constant whistling sound from your nose. This may be sign of damage inside your nose.. oyou get an allergic reaction to this product. Seek medical help right away.. oyou get new changes to your vision that develop after starting this product. oyou have severe or frequent nosebleeds.

OTC - WHEN USING SECTION.


When using this product. othe growth rate of some children may be slowerostinging or sneezing may occur for few seconds right after useodo not share this bottle with anyone else as this may spread germsoremember to tell your doctor about all the medicines you take, including this one. othe growth rate of some children may be slower. ostinging or sneezing may occur for few seconds right after use. odo not share this bottle with anyone else as this may spread germs. oremember to tell your doctor about all the medicines you take, including this one.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Package/Label Principal Display Panel. Compare to Childrens Flonase(R) Allergy Relief active ingredientchildrens24 HOUR RELIEF ALLERGYNasal SprayFLUTICASONE PROPIONULLTE NULLSAL SPRAY, 50 mcg PER SPRAYALLERGY SYMPTOM RELIEVER (GLUCOCORTICOID)FULL PRESCRIPTION STRENGTHNON-DROWSY ALLERGY RELIEF24-HOUR RELIEF24-hour relief of: itchy, watery eyes; nasal congestion; runny nose; itchy nose; sneezingAges years olderFluticasone propionate is steroid medicine known as glucocorticoid.60 METERED SPRAYS 0.34 FL OZ (9.9 mL). childrens nasal spray image.

SPL UNCLASSIFIED SECTION.


Consumer Information. FLUTICASONE PROPIONULLTE NULLSAL SPRAY QUESTIONS ANSWERSWHAT FLUTICASONE PROPIONULLTE NULLSAL SPRAY IS, HOW TO USE IT, AND WHAT TO EXPECT.UNDERSTANDING FLUTICASONE PROPIONULLTE NULLSAL SPRAYWhat Fluticasone Propionate Nasal Spray is, and how it works. What is Fluticasone Propionate Nasal SprayFluticasone Propionate Nasal Spray is an effective, allergy medicine that you can now buy without 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 SprayThe active ingredient in Fluticasone Propionate Nasal Spray is called fluticasone propionate. Fluticasone propionate is 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 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 SprayFor complete guidance, check the Drug Facts label on the back of the Fluticasone Propionate Nasal Spray package.Can use Fluticasone Propionate Nasal Spray for asthmaNo, Fluticasone Propionate Nasal Spray is not treatment for asthma. Ask your doctor what medicine to take for your asthma.Can use Fluticasone Propionate Nasal Spray for coldsNo, use Fluticasone Propionate Nasal Spray to treat only your allergies not your cold symptoms. If youre not sure whether your symptoms come from allergies or cold, ask your doctor.What happens when you have allergiesAllergies start when allergens like pollen or pet dander enter your body and trigger your immune system to respond.Your bodys natural response is to release multiple inflammatory substances, (also referred to as mediators) that cause your allergy symptoms.How does Fluticasone Propionate Nasal Spray workFluticasone Propionate Nasal Spray works right in your nose to help block your allergic reaction at the source to relieve the symptoms that make you uncomfortable.Fluticasone Propionate Nasal Spray acts on multiple inflammatory substances, including histamine, prostaglandins, cytokines, tryptases, chemokines and leukotrienes.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 day.Fluticasone Propionate Nasal Spray not only relieves sneezing, itchy nose, runny nose and itchy, watery eyes, but also relieves nasal congestion.Who should not use Fluticasone Propionate Nasal Spray or check with doctor firstSome people should not use Fluticasone Propionate Nasal Spray, or need to check with health professional first. This table offers quick summary of these situations.If you...Heres what to do...Are younger than 4Do not use Fluticasone Propionate Nasal SprayAre pregnant or breast-feedingTalk to health professional before using Fluticasone Propionate Nasal SprayHave or had glaucoma or cataractsTalk to your doctor before using Fluticasone Propionate Nasal SprayHave an injury or surgery to your nose that is not fully healedDo not use Fluticasone Propionate Nasal SprayHave ever had an allergic reaction to Fluticasone Propionate Nasal Spray or any of its ingredients Do not use Fluticasone Propionate Nasal SprayAre taking medicine for HIV infection (such as ritonavir) Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal SprayAre taking ketoconazole pills (medicine for fungal infection)Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal SprayAre using steroid medicine for asthma, allergies, skin rash, allergic reactions, inflammation or eye conditions Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal SprayWhat problems can Fluticasone Propionate Nasal Spray help withAllergies can cause uncomfortable symptoms like congestion and itchy eyes. These symptoms can be triggered by allergens like pollen, mold, dust or pet dander.Fluticasone Propionate Nasal Spray helps relieve broad range of symptoms from many allergens.For example, Fluticasone Propionate Nasal Spray helps with:SymptomsTriggersNasalsymptomsEyesymptomsOutdoorallergensAnimalallergensIndoorallergenso Congestiono Runny noseo Sneezingo Itchy noseo Itchy eyeso Watery eyeso Weed polleno Grass polleno Tree polleno Mold sporeso Catso Dogso Dusto Dust miteso MoldUSING FLUTICASONE PROPIONULLTE NULLSAL SPRAYHow 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 nasal spray. Why do have to follow the directionsIf you dont use the spray bottle correctly, you might not get full dose. Without full dose each time, you might not get the relief you deserve.Follow the simple directions in the Quick Start Guide on other side.If my symptoms go away, should stop using Fluticasone Propionate Nasal SprayYou 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 allergens that 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 months or age 4-11 and need to use for longer than months year, check with your doctor.What if miss dose by accidentIf you miss dose, just use your regular dose the next day. Dont add an extra dose to make up for it.Can keep using Fluticasone Propionate Nasal Spray year roundSome 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 year, check with your doctor to make sure its OK to keep using Fluticasone Propionate Nasal Spray. In fact, its good idea for anyone with persistent allergies to talk with doctor every so often about symptoms and medicines.Can share my Fluticasone Propionate Nasal SprayDo not share bottle of Fluticasone Propionate Nasal Spray. Sharing the bottle can spread germs, because you insert the nozzle in your nose.Can spray Fluticasone Propionate Nasal Spray in my eyes or mouthNo, Fluticasone Propionate Nasal Spray is meant to work only in your nose to relieve your allergy symptoms, including itchy, watery eyes.Never spray Fluticasone Propionate Nasal Spray in your eyes or your mouth.Some decongestants may increase blood pressure. Does Fluticasone Propionate Nasal Spray increase blood pressureWhen used as directed, Fluticasone Propionate Nasal Spray does not increase blood pressure.Wont waste product by primingIts not waste to prime the pump, because it helps you get full dose. Getting 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 face when priming.How long should bottle of Fluticasone Propionate Nasal Spray lastThis 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 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 sprays1 week2 weeks60 sprays2 weeks4 weeks120 sprays4 weeks8 weeks150 sprays5 weeks10 weeksCheck with doctor if child 4-11 needs to use longer than months yearIs Fluticasone Propionate Nasal Spray OK to use with other medicinesYou 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 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 table to 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 SprayMedicines with glucocorticoidsIncluding some medicines for skin rash such as eczema, asthma, inflammation, allergic reactions, or eye conditionsTalk to your doctor or pharmacist before using Fluticasone Propionate Nasal SprayKetoconazole Pills for fungal infection Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal SprayWhat are the differences in the way children age 4-11 should use Fluticasone Propionate Nasal SprayChildren age 4-11 should use lower dose of Fluticasone Propionate Nasal Spray for shorter period of time. AgesChildren 4-11 years of ageUsers 12 years of age and olderDosage1 spray in eachnostril once daily Up to spraysin each nostril once daily Duration before checking with doctorUp to months of use yearUp to months of daily useWhy is the use of Fluticasone Propionate Nasal Spray for children age 4-11 limited to months year before checking with doctorWhen 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 childs ultimate height is not known. As 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 months year.WHAT TO EXPECTWhat its like to use Fluticasone Propionate Nasal Spray.How soon will get reliefYou 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 lastFluticasone 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 day.Does Fluticasone Propionate Nasal Spray cause rebound effectNo, Fluticasone Propionate Nasal Spray does not cause 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 rebound effect.Fluticasone Propionate Nasal Spray is 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 year if you are age 4-11 before checking with doctor.Will Fluticasone Propionate Nasal Spray make me drowsyNo, 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 smellThe light floral scent you may notice comes 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 outTry priming the spray bottle. It may take 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 feel stinging in my nose, or sneezeSome people may feel slight stinging, or may sneeze, after spraying Fluticasone Propionate Nasal Spray in their nostrils.This feeling should go away in few seconds.What if feel or taste the medicine in my throatGenerally, you can avoid this by taking shallower breath next time you spray Fluticasone Propionate Nasal Spray into your nostrils. For example, take the kind of breath you would use to smell flower.What if have chicken pox, measles or tuberculosis or come into contact with someone who doesStop using Fluticasone Propionate Nasal Spray and ask your doctor.What if Im having severe sinus painIf you feel severe pain in your face, have thick nasal discharge, or think you may have 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 weekIf you have used Fluticasone Propionate Nasal Spray for 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 effectsSerious side effects are rare with 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.Side effectWhat could happenWhat to doAllergic reaction to the productoSudden swelling of face or tongueoA rashoWheezing or feeling faint If you feel any of these symptoms, stop using Fluticasone Propionate Nasal Spray and see doctor right away.Nose injuryoSevere or frequent nosebleedsApply pressure to your nose. Stop using Fluticasone Propionate Nasal Spray and see doctor. oConstant whistling sound that does not go awayThis could be sign of damage to your nose. Stop using Fluticasone Propionate Nasal Spray and see doctor right away.Eye conditions such as cataracts or glaucoma oCloudy visionoReduced vision Have yearly eye exam to check for these conditions. Read the Drug Facts on the back of the Fluticasone Propionate Nasal Spray package for more details.Growth effectsoSlower growth rate in some children while using productTalk to your doctor if you are concerned or if child age 4-11 needs to use Fluticasone Propionate Nasal Spray for longer than two months year. Other side effectsoHeadaches or sneezingoBad taste or smelloMinor nosebleedsoDry or irritated nose or throat. Talk to your doctor or pharmacist if you are concerned.STILL HAVE QUESTIONS Call 1-800-719-9260FLUTICASONE PROPIONULLTE NULLSAL SPRAYQUICK START GUIDEHOW TO START GETTING ALLERGY RELIEF RIGHT NOWUSE THE RIGHT DOSEFluticasone Propionate Nasal Spray works best when you use it daily. Heres how to get started.Children age 4-11An adult should supervise useUse one spray in each nostril once daily.Dont use more than one spray in each nostril per day.If you miss dose, just use your regular dose the next day. Dont add an extra dose.Check with doctor if child needs to use Fluticasone Propionate Nasal Spray for longer than two months year.Users age 12 or olderIn your first weekUse two sprays in each nostril every day.Dont use more than two sprays in each nostril per day.After your first weekIf 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 dose, just use your regular dose the next day. Dont add an extra dose.WARNING:Do not spray in your eyes. Only for use in your nose.KEEP IT CLEANULL clean spray nozzle helps ensure full dose. Clean it weekly, or if its clogged. Dont 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 soft click.If spray nozzle is clogged, soak in warm water. Then repeat steps and 3.GET THE RELIEF YOU NEED.Fluticasone Propionate Nasal Spray can relieve your allergy symptoms. For best results, its important to get full dose.Heres how, in five easy steps.Gently shake spray bottle.Remove clear cap.Do this when:oStarting new bottleoHavent used it in weekoJust cleaned nozzleOtherwise 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 nose gently to clear nostrils.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.While sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). Youll feel light mist in your nose. Breathe out through your mouth.Repeat in other nostril.Wipe spray nozzle with clean tissue and replace cap.Distributed ByPerrigo(R)Allegan, MI 49010:1G70000J4. oSudden swelling of face or tongue. oA rash. oWheezing or feeling faint oSevere or frequent nosebleeds. oConstant whistling sound that does not go away. oCloudy vision. oReduced vision oSlower growth rate in some children while using product. oHeadaches or sneezing. oBad taste or smell. oMinor nosebleeds. oDry or irritated nose or throat. oStarting new bottle. oHavent used it in week. oJust cleaned nozzleOtherwise go to Step 3.. image 1. image 2. image 3. image 4. image 5. image 6. image 7. image 8. image 9. image 10. image 11. image 13. image 14. image 15. image 16. image 17. image 18. image 19. image 20. image 21. image 22. image 23. image 24. image 25.

STORAGE AND HANDLING SECTION.


Other information. oyou may start to feel relief the first day and full effect after several days of regular, once-a-day useostore between and 30C (39 and 86F) okeep this package and enclosed materials. They contain important additional information.. oyou may start to feel relief the first day and full effect after several days of regular, once-a-day use. ostore between and 30C (39 and 86F) okeep this package and enclosed materials. They contain important additional information.

WARNINGS SECTION.


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