Label: LORATADINE tablet, orally disintegrating
- NDC Code(s): 72888-029-09, 72888-029-11
- Packager: Advagen Pharma Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 25, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
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 - 888-413-0949Distributed by:
Advagen Pharma Ltd
666 Plainsboro Road
Suite 605
Plainsboro, NJ 08536, USA.
Manufactured by:
Rubicon Research Private Limited
Ambernath, Dist: Thane, 421506 India. - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72888-029 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) Product Characteristics Color white (White to Off-White) Score no score Shape ROUND Size 10mm Flavor PEPPERMINT Imprint Code UpArrowhead43 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72888-029-09 1 in 1 CARTON 09/10/2020 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:72888-029-11 3 in 1 CARTON 09/10/2020 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214280 09/10/2020 Labeler - Advagen Pharma Limited (051627256) Registrant - Rubicon Research Private Limited (918629544) Establishment Name Address ID/FEI Business Operations Rubicon Research Private Limited 677604197 manufacture(72888-029) , analysis(72888-029) , pack(72888-029)
