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

Questions or comments?

Call 1-800-706-5575, weekdays, 8:30 am - 5:00 pm Eastern Standard Time

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

Revised: August 2018

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 DRUGItem Code (Source)NDC:60505-0147
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
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; Type 0: Not a Combination Product01/24/200506/30/2022
2NDC:60505-0147-81000 in 1 BOTTLE; Type 0: Not a Combination Product01/24/200506/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647101/24/200506/30/2022
Labeler - Apotex Corp. (845263701)

Revised: 8/2019
Document Id: 5401597c-f960-41c2-082f-03dab3118cde
Set id: 679164cc-7505-7ed4-13fe-87f06cb777d8
Version: 4
Effective Time: 20190821
 
Apotex Corp.