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| Product NDC Code | 70000-0204 | ||||
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| Drug Name | Leader nasal allergy |
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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 | 1797913 | ||||
| Application Number | ANDA078104 | ||||
| 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) Triamcinolone acetonide 55 mcg (glucocorticoid)
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) on how to: • get a new bottle ready (primed) before first use • prime bottle again if not used for more than 2 weeks • use the spray • clean the spray nozzle ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12 years of age and older • once daily, spray 2 times into each nostril while sniffing gently • once your allergy symptoms improve, reduce to 1 spray in each nostril per day CHILDREN 2 TO UNDER 12 YEARS OF AGE • the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. children 6 to under 12 years of age • an adult should supervise use • once daily, spray 1 time into each nostril while sniffing gently • if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day. children 2 to under 6 years of age • an adult should supervise use • once daily, spray 1 time into each nostril while sniffing gently children under 2 years of age • do not 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 allergy symptoms do not improve after one week, stop using and talk to a doctor • do not use for the common cold • shake well before each use
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid or sodium hydroxide (for pH adjustment), microcrystalline cellulose, polysorbate 80, purified water
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 Allergy Triamcinolone acetonide TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE BENZALKONIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM ANHYDROUS DEXTROSE EDETATE DISODIUM HYDROCHLORIC ACID SODIUM HYDROXIDE MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 WATER off white
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 TM Multi-Symptom Nasal Allergy Spray 24 Hour Triamcinolone Acetonide Nasal Spray, 55 mcg per spray Allergy Symptom Reliever (Glucocorticoid)* Original Prescription Strength 24 HR Relief of: Nasal Congestion, Sneezing, Runny Nose, Itchy Nose COMPARE TO NASACORT ® ALLERGY 24HR active ingredient Scent-Free Non-Drowsy Alcohol-Free 100% Money Back Guarantee *Triamcinolone acetonide is a steroid medicine known as a glucocorticoid. 0.57 FL OZ (16.9 mL) 120 SPRAYS nasal allergy spray 24 hour 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 Triamcinolone Acetonide Nasal Spray 55 mcg per spray IMPORTANT INFORMATION • Read both sides of this insert for complete instructions on how to get a bottle ready (primed), how to use the spray bottle and how to clean the spray nozzle. • Keep this insert as it contains important information. STEPS TO GET A NEW BOTTLE READY FOR USE (PRIMED) 1. Before first use, a new bottle must be primed. a. Remove cap and safety clip (Figure A) . b. Shake bottle. c. Press and release spray nozzle until a fine mist is produced (as shown in Figure B) . This may take several times. Take care not to spray in face. PRIME BOTTLE AGAIN IF NOT USED FOR MORE THAN 2 WEEKS • Repeat steps for priming a bottle (see above). USE INSTRUCTIONS 1. Blow nose gently to clear nostrils. 2. Remove cap and safety clip, then shake bottle. 3. Hold bottle with thumb under bottle and spray nozzle between fingers (as shown in Figure B) . 4. Press against the outside of your nose with your finger to close off one nostril (as shown in Figure C) . 5. Place the tip of the spray nozzle into the other nostril. The spray nozzle should not reach far into the nose. Aim nozzle toward back of nose (as shown in Figure C) . DO NOT spray toward nasal septum (the wall between the 2 nostrils) (as shown in Figure D) . 6. While sniffing gently, spray into nostril. IMPORTANT: For complete dosing instructions, See “Directions for use” on next side. 7. Repeat steps “4” through “6” for the other nostril. 8. After using the nasal spray, wipe nozzle with a tissue, replace safety clip, and replace cap by pressing it down over the spray nozzle. NOTE: Avoid blowing nose for 15 minutes after use. If nozzle does not spray properly, see cleaning instructions on next side. (continued on side 2) SIDE 1 DIRECTIONS FOR USE • BEFORE first use, you must get a new bottle ready (primed). • If bottle is not used for more than 2 weeks, prime bottle again. Dosing ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12 years of age and older • once daily, spray 2 times into each nostril while sniffing gently • once your allergy symptoms improve, reduce to 1 spray in each nostril per day CHILDREN 2 TO UNDER 12 YEARS OF AGE • the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. children 6 to under 12 years of age • an adult should supervise use • once daily, spray 1 time into each nostril while sniffing gently • if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day. children 2 to under 6 years of age • an adult should supervise use • once daily, spray 1 time into each nostril while sniffing gently children under 2 years of age • do not use 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. IF PUMP DOES NOT SPRAY PROPERLY, THE NOZZLE MAY BE BLOCKED 1. Never try to unblock nozzle with a pin or any other object (as shown in Figure E). 2. Clean the nozzle as shown below. CLEANING INSTRUCTIONS 1. Gently pull spray nozzle away from bottle (as shown in Figure F). 2. Rinse SPRAY NOZZLE ONLY under warm water (as shown in Figure G) . 3. Shake or tap to remove excess water. 4. Re-attach spray nozzle to bottle. 5. Press and release spray nozzle until a fine spray is produced, taking care not to spray in face. Triamcinolone Acetonide Nasal Spray pump is now ready to use. Where can I get more information? 1-800-719-9260 Store between 20°-25°C (68°-77°F) Made in Israel Distributed By Perrigo® Allegan, MI 49010 SIDE 2 : 44300 00 J4 Figure A Figure B Figures C & D Figure E Figure F Figure G
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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 before use if • have had recent nose ulcers or nose surgery • have had a nose injury that has not healed • are using a steroid medicine for asthma, allergies or skin rash • have an eye infection • have or had glaucoma or cataracts
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 • if you have ever had an allergic reaction to 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? 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 • you have or develop symptoms of an infection such as a persistent fever • you have any change in vision • 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 • some symptoms may get better on the first day of treatment. It may take up to one week of daily use to feel the most symptom relief. • 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 printed bottle wrap is torn or opened • keep package and insert. They contain important information. • store between 20 o -25 o C (68 o -77 o 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 Do not use • in children under 2 years of age • if you have ever had an allergic reaction to any of the ingredients Ask a doctor before use if • have had recent nose ulcers or nose surgery • have had a nose injury that has not healed • are using a steroid medicine for asthma, allergies or skin rash • have an eye infection • have or had glaucoma or cataracts When using this product • the growth rate of some children may be slower • some symptoms may get better on the first day of treatment. It may take up to one week of daily use to feel the most symptom relief. • 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 • you have or develop symptoms of an infection such as a persistent fever • you have any change in vision • 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