LEADER LORATADINE- loratadine tablet

LEADER Loratadine by

Drug Labeling and Warnings

LEADER Loratadine by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• runny nose
• itchy, watery eyes
• sneezing
• itching of the nose or throat

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

• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
• store between 20 and 25° C (68 and 77° F)
• protect from excessive moisture

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®.

10's Blister Carton

90's Bottle Carton

INGREDIENTS AND APPEARANCE

LEADER LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-346
Route of Administration	ORAL

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)