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| Product NDC Code | 37808-340 | ||||
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| Drug Name | Childrens nasopro |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | NASAL | ||||
| Dosage Form | SPRAY, METERED | ||||
| RxCUI drug identifier | 1797907, 1872967 |
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| Application Number | ANDA207957 | ||||
| Labeler Name | H E B | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each spray) Fluticasone propionate (glucocorticoid) 50 mcg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water, sodium carboxymethylcellulose
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes
Purpose
Information about the drug product’s indications for use.Purpose Allergy symptom reliever
Spl product data elements
Usually a list of ingredients in a drug product.Childrens Nasopro fluticasone propionate FLUTICASONE PROPIONATE FLUTICASONE BENZALKONIUM CHLORIDE DEXTROSE, UNSPECIFIED FORM MICROCRYSTALLINE CELLULOSE PHENYLETHYL ALCOHOL POLYSORBATE 80 WATER CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Principal Display Panel Compare to Children’s Flonase ® Allergy Relief active ingredient Children’s Nasopro 24 ® Allergy Relief Fluticasone Propionate Nasal Spray 50 mcg Per Spray Allergy Symptom Reliever (Glucocorticoid)* 24 Hour Relief 24 Hour Relief of: - Itchy, Watery Eyes - Nasal Congestion – Runny Nose - Itchy Nose – Sneezing Non-Drowsy Ages 4 Years & Older *Fluticasone propionate is a steroid medicine known as a glucocorticoid. Full Prescription Strength 72 METERED SPRAYS 0.38 FL OZ (11.1 mL) childrens nasopro 24 image
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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 medicine that 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. It’s 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 allergies – not your cold symptoms. If you’re not sure whether your symptoms come from allergies or a cold, ask your doctor. What happens when you have allergies? Allergies start when allergens like pollen or pet dander enter your body and trigger your immune system to respond. Your body’s natural response is to release multiple inflammatory substances, (also referred to as mediators) that cause your allergy symptoms. How does Fluticasone Propionate Nasal Spray work? Fluticasone 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. That’s why it’s best to use Fluticasone Propionate Nasal Spray regularly, once a 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 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… Here’s 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 nose that is not fully healed Do not use Fluticasone Propionate Nasal Spray Have ever had an allergic reaction to Fluticasone Propionate Nasal Spray or any of its ingredients Do not use Fluticasone Propionate Nasal Spray Are taking a 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 and itchy eyes. These symptoms can be triggered by allergens like pollen, mold, dust or pet dander. Fluticasone Propionate Nasal Spray helps relieve a broad range of symptoms from many allergens. For example, Fluticasone Propionate Nasal Spray helps with: Nasal symptoms Eye symptoms Outdoor allergens Animal allergens Indoor allergens • Congestion • Itchy eyes • Weed pollen • Cats • Dust • Runny nose • Watery eyes • Grass pollen • Dogs • Dust mites • Sneezing • Tree pollen • Mold • Itchy nose • Mold spores 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 don’t 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 Guide on 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. It’s important you keep using Fluticasone Propionate Nasal Spray daily as long as you’re exposed to allergens that bother you, like pollen, mold, dust or pet dander. This way you’ll 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. Don’t 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 it’s OK to keep using Fluticasone Propionate Nasal Spray daily. In fact, it’s 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 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 pressure? When used as directed, Fluticasone Propionate Nasal Spray does not increase blood pressure. Won’t I waste product by priming? It’s 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. Don’t 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 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 you’ve 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… 60 sprays 2 weeks 4 weeks 72 sprays 2 weeks 5 weeks 120 sprays 4 weeks 8 weeks 144 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 table to see if you’re taking any of these medicines. If you’re taking… Here’s what to do… Medicines for HIV infection (such as ritonavir) Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray Medicines with glucocorticoids Including 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 Ketoconazole Pills 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 dose of 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 child’s 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 child’s doctor if your child needs to use the spray for longer than 2 months a year. WHAT TO EXPECT What it’s 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, it’s 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 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 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 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 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 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 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 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 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 effect What could happen What to do Allergic reaction to the product • Sudden swelling of face or tongue • A rash • Wheezing or feeling faint If you feel any of these symptoms, stop using Fluticasone Propionate Nasal Spray and see a doctor right away. Nose injury • Severe or frequent nosebleeds Apply pressure to your nose. Stop using Fluticasone Propionate Nasal Spray and see a doctor. • Constant whistling sound that does not go away This could be a sign of damage to your nose. Stop using Fluticasone Propionate Nasal Spray and see a doctor right away. Eye conditions such as cataracts or glaucoma • Cloudy vision • Reduced vision Have a 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 effects • Slower growth rate in some children while using product 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 • Headaches or sneezing • Bad taste or smell • Minor nosebleeds • Dry or irritated nose or throat. Talk to your doctor or pharmacist if you are concerned. STILL HAVE QUESTIONS? Call 1-800-719-9260 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. Here’s how to get started. Children age 4-11 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 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 can relieve your allergy symptoms. For best results, it’s important to get a full dose. Here’s how, in five easy steps. Gently shake spray bottle. Remove clear cap. 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 . 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). 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 Perrigo ® Allegan, MI 49010 1G700 00 J5: image 1 Image 2 Image 3 image 3 image 9 image 10 image 11 image 12 image 13 image 14 image 15 image 16 image 17 image 18 image 19 image 20 image 21 image 22 image 23
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Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have or had glaucoma or cataracts
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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 package and enclosed materials. They contain important additional information.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-719-9260
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API