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| Product NDC Code | 70000-0635 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Leader nasal |
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| Type | Brand | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], 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 | 1797865 | ||||||
| Application Number | NDA215712 | ||||||
| Labeler Name | Cardinal Health 110, LLC. dba Leader | ||||||
| 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) Mometasone furoate monohydrate (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 insert (inside package) for how to: • prime the bottle • use the spray • clean the nozzle • shake well before each use • use this product only once a day • do not use more than directed Adults & children 12 years of age and older • 2 sprays in each nostril once daily while sniffing gently Children 2 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 • 1 spray in each nostril once daily while sniffing gently Children under 2 years of age • do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, sodium citrate
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
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.Leader Nasal mometasone furoate MOMETASONE FUROATE MONOHYDRATE MOMETASONE MOMETASONE FUROATE BENZALKONIUM CHLORIDE CITRIC ACID MONOHYDRATE GLYCERIN MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POLYSORBATE 80 WATER SODIUM CITRATE, 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 LEADER ™ Non-Drowsy | Scent-Free Mist Allergy Nasal Spray Mometasone Furoate Nasal Spray, 50 mcg Per Spray Allergy Symptom Reliever (Glucocorticoid)* Allergy + Congestion Full Prescription Strength 24HR Relief Of: Nasal Congestion Runny Nose Sneezing Itchy Nose COMPARE TO NASONEX ® 24HR ALLERGY active ingredient 100% Money Back Guarantee *Mometasone furoate is a steroid medicine known as a glucocorticoid 60 SPRAYS 0.34 FL OZ (10.0 mL) Allergy Nasal Spray Carton Image 1 Allergy Nasal Spray Carton Image 2 Allergy Nasal Spray Label
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 Mometasone Furoate Nasal Spray, 50 mcg/Spray 1Y800 00 J2 A GETTING STARTED This product works best at relieving your allergy symptoms when you get a full dose. Here’s how to get started, in five easy steps. 1 SHAKE Shake spray bottle well. Remove cap. 2 PRIME Do this when: • Starting a new bottle • Bottle has not been used in one week • Just cleaned nozzle Otherwise go to step 3 Aim away from the face. Grasp spray bottle as shown. Pump until fine mist appears. Pumped ten times and still no mist? Spray nozzle may be clogged. See KEEP IT CLEAN, other side. NOTE: There is enough medicine in the bottle to allow for priming sprays plus the number of sprays labeled on the bottle. 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. Dosing and Cleaning instructions See other side SIDE 1 B DIRECTIONS FOR USE This product works best when you use it daily. Here’s how to get started. Children age 2-11 An adult should supervise use Use one spray in each nostril once daily. Check with your child’s doctor if child needs to use this product for longer than two months a year. WARNING: Do not spray in your eyes. Only for use in your nose. Users age 12 or older Use two sprays in each nostril every day. Other important information for use • Do not use more than directed. • If you forget a dose, do not double the next dose. • Do not spray into eyes or mouth. • If you get the spray in your eyes, rinse well with water. • If allergy symptoms do not improve after one week, stop using and talk to a doctor. • Do not share this bottle with anyone else as this may spread germs. C 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 water, and dry at room temperature. Aim away from your face and gently, but firmly replace spray nozzle. If spray nozzle is clogged, soak in warm water. Then repeat steps 2 and 3 . Questions or comments? Call toll-free 1-800-719-9260 Store between 20º-25ºC (68º-77ºF) Distributed By Perrigo ® Allegan, MI 49010 SIDE 2 Shake bottle Remove cap Prime blow image Aim image tip image aim slightly image while sniffing image 1x each nostril image warning image two times image remove nozzle image Rinse image replace nozzle image Soak image
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 an eye infection • 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 2 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).
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 1-800-719-9260
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 chickenpox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get a new symptom 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 may occur for a few seconds right after use • you may start to feel relief within 12 hours and full effect after several days of regular, once-a-day 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 • do not use if sealed package is torn or opened • keep package and insert. They contain important information. • store between 20-25 ° C (68-77 ° F)
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 2 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 an eye infection • 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 may occur for a few seconds right after use • you may start to feel relief within 12 hours and full effect after several days of regular, once-a-day 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 chickenpox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get a new symptom 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