LORATADINE- loratadine tablet 
Apotex Corp.

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Loratadine Tablet 10 mg

Drug Facts

Active ingredient (in each tablet)

Loratadine 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

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

Manufactured by:Manufactured for:
Apotex Inc.Apotex Corp.
Toronto, OntarioWeston, Florida
Canada M9L 1T933326

Revised: March 2005

PRINCIPAL DISPLAY PANEL - 10 mg

APOTEX CORP. NDC 60505-0147-1

Loratadine Tablets 10 mg

Non-Drowsy*

Antihistamine/Original Prescription Strength 

Compare to the active ingredient in Claritin® Tablets

Indoor & Outdoor Allergies

24 hour

Relief of

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:60505-0147
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint Code LOR;10;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-0147-1100 in 1 BOTTLE
2NDC:60505-0147-81000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647101/24/2005
Labeler - Apotex Corp. (845263701)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc.205576023manufacture(60505-0147), analysis(60505-0147)

Revised: 2/2012
Document Id: b91700ac-cb4f-f19d-53ad-505fa5634309
Set id: 679164cc-7505-7ed4-13fe-87f06cb777d8
Version: 1
Effective Time: 20120208
 
Apotex Corp.