LORATADINE - loratadine tablet 
Sandoz Inc

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Drug Facts

Active Ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

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 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

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

• Safety sealed: do not use if the imprinted bottle seal is open or torn.

• Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

1-800-525-8747

03-2008M

Sandoz Inc.

Princeton, NJ 08540

10 mg Label

NDC 0781-5077-01 Non-Drowsy*

LORAtadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

100 Tablets

Sandoz

24 Hour

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery

Eyes

• Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.

LORATADINE  loratadine   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0781-5077 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 LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE (white to off white) Score no score Shape ROUND Size 6mm Flavor Imprint Code GG296 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0781-5077-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075209	01/21/2003

Labeler - Sandoz Inc (110342024)

Establishment
Name	Address	ID/FEI	Operations
Sandoz Inc		110342024	MANUFACTURE

Revised: 12/2009Sandoz Inc