LORATADINE LORATADINE ADVAGEN PHARMA LIMITED FDA Approved No description available yet.
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Substance Loratadine
Route
ORAL
Applications
ANDA214280

Drug Facts

Composition & Profile

Active Ingredients
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 - 866-488-0312 Distributed by: Advagen Pharma Ltd East Windsor NJ 08520 USA Manufactured by: Rubicon Research Ltd. Thane 421506 India. Rev. 02 11/24
Strengths
10 mg 1.52 mg/10 mg
Quantities
10 tablets 30 tablets 10 count 30 count
Pill Appearance
Shape: round Color: white Imprint: UpArrowhead43

Identifiers & Packaging

Container Type UNKNOWN
UPC
0372888029115
UNII
7AJO3BO7QN
Packaging

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

Package Descriptions
  • 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

Overview

No description available yet.

Dosage & Administration

Not available

Warnings & Precautions
No warnings available yet.

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