LORATADINE- loratadine tablet 
Shopko Stores Operating Co., LLC

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:37012-526
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color white (White to off-White) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RX526
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37012-526-69 10 in 1 BLISTER PACK
2 NDC:37012-526-31 30 in 1 BLISTER PACK
3 NDC:37012-526-60 60 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076134 08/19/2003
Labeler - Shopko Stores Operating Co., LLC (023252638)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(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