LORATADINE tablet, orally disintegrating

LORATADINE by

Drug Labeling and Warnings

LORATADINE by is a Otc medication manufactured, distributed, or labeled by Advagen Pharma Limited, Rubicon Research Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 - 888-413-0949
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.

PURPOSE

INDICATIONS & USAGE

WARNINGS

DOSAGE & ADMINISTRATION

SPL UNCLASSIFIED SECTION

INACTIVE INGREDIENT

QUESTIONS

SPL UNCLASSIFIED SECTION

Note: Imprint Code - Λ indicated as UpArrowhead in Drug Listing Data Element (DLDE) section.

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

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet, orally disintegrating

Product 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)