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| Product NDC Code | 0135-0576 | ||||||||||||||||||||||
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| Drug Name | Flonase allergy relief |
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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, 1797933 |
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| Application Number | NDA205434 | ||||||||||||||||||||||
| Labeler Name | Haleon US Holdings LLC | ||||||||||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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: o prime the bottle o use the spray o 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethylalcohol, 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.FLONASE ALLERGY RELIEF fluticasone propionate FLUTICASONE PROPIONATE FLUTICASONE BENZALKONIUM CHLORIDE DEXTROSE, UNSPECIFIED FORM MICROCRYSTALLINE CELLULOSE PHENYLETHYL ALCOHOL POLYSORBATE 80 WATER CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
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.Principal Display Panel NDC 0135-0576-03 FLONASE® ALLERGY RELIEF FULL PRESCRIPTION STRENGTH * NON-DROWSY Fluticasone Propionate (Glucocorticoid) 50 mcg Per Spray Allergy Symptom Reliever Nasal Spray 24 Hour Relief of: • Itchy, Watery Eyes • Nasal Congestion • Runny Nose • Itchy Nose • Sneezing 24 HOUR RELIEF 120 METERED SPRAYS 0.54 fl oz (15.8 mL) FLONASE, the FLONASE logo, the bottle and cap design, and other design elements are trademarks of the GSK group of companies. IMPORTANT – Peel here for complete Drug Facts label. Children 4-11: do not use for more than 2 months a year. Be sure to read the Quick Start Guide and Question & Answer Book inside package TAMPER-EVIDENT features for your protection. The product is packaged in a sealed plastic container. Under the cap and nozzle, each bottle has an aluminum seal around bottle neck. Do not use if any of these features are torn or damaged. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 Made in Canada What problems can FLONASE ® Allergy Relief help with? FLONASE ® Allergy Relief helps relieve a broad range of uncomfortable symptoms like congestion and itchy eyes. Nasal symptoms Eye symptoms These symptoms can be triggered by allergens like pollen, mold, dust or pet dander. Outdoor allergens Animal allergens Indoor allergens Blister card: 104447XB ©2015 GSK Peel Back Label: 104448XB ©2015 GSK Flonase 120 count backcard
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.
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? call toll-free 1-844-FLONASE (1-844-356-6273) (English/Spanish) weekdays
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.
Storage and handling
Information about safe storage and handling of the drug product.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 label and enclosed materials. They contain important additional information.
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.
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