LORATADINE- loratadine tablet 
Sandoz Inc

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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 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

  • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
  • Safety sealed: do not use if open or torn (for blister package only).

  • 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

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
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: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) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code GG296
Contains    
Packaging
#Item CodePackage Description
1NDC:0781-5077-641 in 1 CARTON
130 in 1 BLISTER PACK
2NDC:0781-5077-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520901/21/2003
Labeler - Sandoz Inc (110342024)

Revised: 10/2011
Document Id: 75c077cc-6055-45d1-b3f4-2207235807f2
Set id: a0593748-88fe-481f-9608-740ea6a304e7
Version: 13
Effective Time: 20111020
 
Sandoz Inc