LORATADINE ODT- loratadine tablet, orally disintegrating 
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

OTHER INFORMATION

INACTIVE INGREDIENTS

Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

SHOPKO®

Compare to the Active Ingredient of Claritin®RediTabs®

Original Prescription Strength

Allergy Relief

Loratadine Orally Disintegrating Tablets, USP 10 mg

Antihistamine

Non-Drowsy*

Indoor & Outdoor Allergies

24 Hour Allergy Relief

For Adults and Children six years and older!

Relief of: Sneezing, Runny Nose, Itchy/Watery Eyes, Itchy Throat or Nose

No Water NeededMelts in Your Mouth

*When taken as directed. See Drug Facts Panel.

Manufactured by: Ohm Laboratories Inc.

5093689/R0512

30's blister carton label
LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-527
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
ASPARTAME (UNII: Z0H242BBR1)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
Color white (White to Off-White) Score no score
Shape ROUND (Flat Faced Beveled Edge) Size 10mm
Flavor MINT, STRAWBERRY, TUTTI FRUTTI Imprint Code RC17
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37012-527-31 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077153 08/31/2007
Labeler - Shopko Stores Operating Co., LLC (023252638)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(37012-527)

Revised: 3/2013
Document Id: 03adedd8-1cda-4e10-a2a2-5680a260809e
Set id: 8d7cedb3-6edc-4e9d-9f18-08158d176fdd
Version: 1
Effective Time: 20130321
 
Shopko Stores Operating Co., LLC