LEADER LORATADINE- loratadine tablet 
Cardinal Health

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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.

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

Keep the carton. It contains important information.

See end panel for expiration date.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

NDC 37205-346-52

LEADER®

Compare to Claritin®active ingredient

Non-Drowsy*

ORIGINAL PRESCRIPTION STRENGTH

Loratadine

Loratadine Tablets USP, 10 mg/Antihistamine

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.

10 TABLETS

Thisproduct is not manufactured or distributed by Schering-Plough HealthCare Products, Inc.,owner of theregisteredtrademarkClaritin®.

This is the 10 count blister carton label for Leader Loratadine tablets USP, 10 mg.

10's Blister Carton

This is the 90 count bottle carton label for Leader Loratadine tablets USP, 10 mg.

90's Bottle Carton

LEADER LORATADINE 
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-346
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:37205-346-52 10 in 1 BLISTER PACK
2 NDC:37205-346-60 20 in 1 BLISTER PACK
3 NDC:37205-346-65 30 in 1 BLISTER PACK
4 NDC:37205-346-72 60 in 1 BOTTLE
5 NDC:37205-346-75 90 in 1 BOTTLE
6 NDC:37205-346-47 150 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076134 08/19/2003
Labeler - Cardinal Health (097537435)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(37205-346)

Revised: 3/2012
Document Id: fe6bc6f0-dfff-49a9-8251-43dfa0a48df2
Set id: e283afb8-9d26-4bd9-be77-e95e1d88aef8
Version: 2
Effective Time: 20120319
 
Cardinal Health