LORATADINE- loratadine tablet 
Major Pharmaceuticals

----------

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:

1.
runny nose
2.
sneezing
3.
itchy, watery eyes
4.
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

1.
store between 2° and 30°C (36° and 86°F)
2.
protect from excessive moisture
3.
This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

Inactive ingredients

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

Questions or comments? 

Call (800) 616-2471

Generic Section

Distributed by:

Distributed By:

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

MADE IN CANADA

Principal Display Panel

Loratadine Tablets, USP

10 mg

100 Tablets

carton label
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5793(NDC:0536-1092)
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:0904-5793-61100 in 1 CARTON06/22/201606/30/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647106/22/201606/30/2020
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)

Revised: 12/2019
Document Id: 61657bee-6af6-47f7-8f97-a18f4530d133
Set id: 036a300c-ba0a-46f4-b125-a30f880e28e6
Version: 4
Effective Time: 20191210
 
Major Pharmaceuticals