LORATADINE- loratadine tablet 
Shopko Stores Operating Co., LLC

----------

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:

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 (1-800-222-1222).

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

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

SHOPKO®

Compare to the Active Ingredient of Claritin®

Original Prescription Strength

Allergy Relief

Loratadine Tablets, USP 10 mg

Antihistamine

Non-Drowsy*

Indoor & Outdoor Allergies

24 Hour Allergy Relief

Relief of:

Sneezing, Runny Nose, Itchy/Watery Eyes, Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

Manufactured by: Ohm Laboratories Inc.

5093684/R0412

This is the 10 count blister carton label for Shopko Loratadine tablets, USP 10 mg
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37012-526
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
STARCH, PREGELATINIZED CORN 
Product Characteristics
Colorwhite (White to off-White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-526-6910 in 1 BLISTER PACK
2NDC:37012-526-3130 in 1 BLISTER PACK
3NDC:37012-526-6060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/19/2003
Labeler - Shopko Stores Operating Co., LLC (023252638)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(37012-526)

Revised: 2/2013
Document Id: 21c4e5cc-a1e7-467c-ab88-a2cde5b56c68
Set id: 9d8888e6-26d6-48cb-afa1-34880dcf668e
Version: 1
Effective Time: 20130205
 
Shopko Stores Operating Co., LLC