LORATADINE ODT- loratadine tablet, orally disintegrating 
Topco Associates 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 1-888-423-0139

PRINCIPAL DISPLAY PANEL

Topcare®

NDC 36800-528-69

Ages 6 years and older

Children's MELT-IN-YOUR-MOUTH TABLETS. NO WATER NEEDED

Original Prescription Strength

24 HOUR NON-DROWSY*

Allergy Relief

LORATADINE ORALLY DISINTEGRATING TABLETS, USP 10 mg

ANTIHISTAMINE

Indoor & Outdoor Allergies

For 24 Hour Relief of:

COMPARE TO CLARITIN®REDITABS®active ingredient

10 ORALLY DISINTEGRATING TABLETS

*When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

5095193/R812

This is the 10 count blister carton label for TopCare Loratadine ODT, USP 10 mg (Children's).
LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-528
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 STRAWBERRY, TUTTI FRUTTI, MINT Imprint Code RC17
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-528-69 10 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 - Topco Associates LLC (006935977)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(36800-528)

Revised: 4/2012
Document Id: dc5acc2d-e646-4db3-97f2-77e16b4b34ef
Set id: 52e8e5c4-a552-4adf-b71b-9259e7822fae
Version: 1
Effective Time: 20120404
 
Topco Associates LLC