LORATADINE  - loratadine tablet 
International Labs, Inc.

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LORATADINE TABLETS USP - PACKAGE LABELS

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

Temporarily relieves the symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• itchy watery nose
• sneezing
• itching of the nose and throat
  

WARNINGS

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 overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Directions

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

Other Information

• TAMPER-EVIDENT: Do not use this product if plastic shell is not intact, blister backing appears to be disturbed or if individual blister units are broken or torn.
• store between 2o and 30oC (36o and 86oF)
• protect from excessive moisture
  

INACTIVE INGREDIENTS

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose mohohydrate, magnesium stearate, microcrystalline cellulose

LORATADINE TABLETS, USP 10 mg - Label

LB0092 - Loratadine Tablets, USP 10 mg

LORATADINE  loratadine   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54458-942 (60505-0147) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color white (off white) Score no score Shape OVAL Size 8mm Flavor Imprint Code APO;LOR;10 Contains

Packaging # NDC Package Description Multilevel Packaging 1 54458-942-10 30 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076471	07/13/2009

Labeler - International Labs, Inc. (023569924)

Registrant - International Labs, Inc. (023569924)

Establishment
Name	Address	ID/FEI	Operations
International Labs, Inc.		023569924	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Operations
Apotex Inc.		205576023	manufacture

Revised: 03/2010International Labs, Inc.