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Loratadine by Sandoz Inc

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Sandoz Inc
NDC Code: 0781-5077

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 (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 
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 CodeGG296
Contains    
Packaging
#Item CodePackage Description
1NDC:0781-5077-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520901/21/2003
Labeler - Sandoz Inc (110342024)

Revised: 10/2012
 
Sandoz Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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