LORATADINE - loratadine tablet 
Sandoz Inc

----------

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:

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 over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

Inactive Ingredients

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

Questions or comments?

1-800-525-8747

05-2010M

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 10 mg Label

10 mg Blister Pack

NDC 0781-5077-64

LORAtadine Tablets, USP 10 mg

10-2009M

Loratadine 10 mg Blister Pack

10 mg Blister Pack Carton

NDC 0781-5077-64

Non-Drowsy*

LORAtadine

Tablets, USP

10 mg Antihistamine

Indoor & Outdoor Allergies

30 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose

Loratadine 10 mg Blister Pack Carton

LORATADINE 
loratadine   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0781-5077
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITE (white to off white) Score no score
ShapeROUNDSize6mm
FlavorImprint Code GG296
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10781-5077-7612 CARTON In 1 CARTONcontains a CARTON (0781-5077-64)
10781-5077-641 BLISTER PACK In 1 CARTONThis package is contained within the CARTON (0781-5077-76) and contains a BLISTER PACK
130 TABLET In 1 BLISTER PACKThis package is contained within a CARTON (0781-5077-64) and a CARTON (0781-5077-76)
20781-5077-01100 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520901/21/2003

Labeler - Sandoz Inc (110342024)
Establishment
NameAddressID/FEIOperations
Sandoz Inc110342024MANUFACTURE
Establishment
NameAddressID/FEIOperations
Thermo-Pak, Inc161049044PACK, LABEL
Revised: 06/2010Sandoz Inc