RxNorm Names

Review RxNorm Normal Forms

LEADER LORATADINE (loratadine) tablet
[Cardinal Health]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e283afb8-9d26-4bd9-be77-e95e1d88aef8

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		Abbreviated New Drug Application

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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®.

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 (LORATADINE)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN

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
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: 03/2012

Document Id: fe6bc6f0-dfff-49a9-8251-43dfa0a48df2

Set id: e283afb8-9d26-4bd9-be77-e95e1d88aef8

Version: 2

Effective Time: 20120319

Cardinal Health

Daily Med

Current Medication Information

Options

Additional Resources