LORATADINE by AMZ789 LLC / Nutra-Med Packaging Inc. / Granules India Limited LORATADINE tablet

LORATADINE by

Drug Labeling and Warnings

LORATADINE by is a Otc medication manufactured, distributed, or labeled by AMZ789 LLC, Nutra-Med Packaging Inc., Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Loratadine 10mg

PURPOSE

Antihistamine

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 this 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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Adults and children 6 years and over 1 tablet daily: no 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

SAFE HANDLING WARNING

Other Information ● store between 20-25°C (68-77°F) ● protect from excessive moisture ● do not use if imprinted seal under safety cap is broken or missing

INACTIVE INGREDIENT

Inactive Ingredients lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73629-003
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73629-003-18	180 in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210722	03/30/2022

Labeler - AMZ789 LLC (117410213)

Establishment
Name	Address	ID/FEI	Business Operations
Nutra-Med Packaging Inc.		022004902	pack(73629-003)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(73629-003)