LORATADINE- loratadine tablet 
Apotex Corp.

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Drug Facts

Active ingredient (in each tablet)

Loratadine, USP 10

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to thisproduct 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

  • store between 2° and 30°C (36° and 86°F)
  • do not use if seal under bottle cap is broken or missing
  • protect from excessive moisture

Inactive ingredients

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

Questions or comments? 

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

Principal Display Panel

Just Well NDC 60505-4649-3

Non-Drowsy*

Loratadine Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour

Relief of:

Sneezing Runny Nose 

Itchy, Watery Eyes 

Itchy Throat or Nose

Just-well-LBL-10mg-365

Principal Display Panel

Just Well NDC 60505--4649-3

Non-Drowsy*

Loratadine Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Just-well-CTN-10mg-365

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-4649
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:60505-4649-3365 in 1 BOTTLE; Type 0: Not a Combination Product11/21/201710/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647111/21/201710/31/2021
Labeler - Apotex Corp. (845263701)

Revised: 8/2019
Document Id: 0bd4bb1d-84e4-4a03-03f4-865c2e1419c3
Set id: e49f5425-9aef-798c-d215-e418e4faf8c2
Version: 2
Effective Time: 20190821
 
Apotex Corp.