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| Product NDC Code | 72888-029 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Loratadine |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, ORALLY DISINTEGRATING | ||||||
| RxCUI drug identifier | 311373 | ||||||
| Application Number | ANDA214280 | ||||||
| Labeler Name | Advagen Pharma Limited | ||||||
| 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.Drug Facts Active ingredient (in each tablet) Purpose Loratadine USP, 10 mg………………………………….....................Antihistamine Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ itchy, watery eyes ■ sneezing ■ itching of the nose or throat Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using a product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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. Directions place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor Other information Phenylketonurics: contains phenylalanine (a component of aspartame) 1.52 mg per 10 mg orally disintegrating tablet. safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablets USP 10 mg is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister FDA approved acceptance criteria for assay and organic impurities differs from USP test Inactive ingredients aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate Questions or comments? Advagen - 888-413-0949 Distributed by: Advagen Pharma Ltd 666 Plainsboro Road Suite 605 Plainsboro, NJ 08536, USA. Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India.
| Loratadine USP, 10 mg………………………………….....................Antihistamine | |
| |
| adults and children 6 years and over | 1 tablet daily; not more than 1 tablet in 24 hours |
| Children under 6 years of age | ask a doctor |
| Consumers with liver or kidney disease | ask a doctor |
| |
| aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate | |
| | |
Spl product data elements
Usually a list of ingredients in a drug product.LORATADINE LORATADINE ASPARTAME SILICON DIOXIDE CROSPOVIDONE MAGNESIUM STEARATE STARCH, CORN MANNITOL MICROCRYSTALLINE CELLULOSE SODIUM STEARYL FUMARATE LORATADINE LORATADINE White to Off-White UpArrowhead43
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 Loratadine Orally Disintegrating Tablets USP 10 mg - 10 Tablets - NDC 72888-029-09 Loratadine Orally Disintegrating Tablets USP 10 mg - 30 Tablets - NDC 72888-029-11 loratadine-odt-usp-10mg-10count loratadine-odt-usp-10mg-30count
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.Note: Imprint Code - Λ indicated as UpArrowhead in Drug Listing Data Element (DLDE) section.
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