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LORATADINE by Apotex Corp.

Medically reviewed on November 21, 2017

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Apotex Corp.
NDC Code: 60505-4649

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

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

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-4649
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 CodeLOR;10;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:60505-4649-3365 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647111/21/2017
Labeler - Apotex Corp. (845263701)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIOperations
Apotex Inc.205576023analysis(60505-4649), manufacture(60505-4649)

 
Apotex Corp.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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