RxNorm Names

Review RxNorm Normal Forms

LORATADINE tablet
[Premier Value]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=778a6979-ea47-4381-8c40-84b3c2325a7e

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

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

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.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-526-69

Original Prescription Strength

NON-DROWSY*

24 Hour Allergy Relief

Loratadine Tablets USP, 10 mg

Allergy Relief

Indoor & Outdoor Allergies

Antihistamine

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

10 TABLETS

COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN®†

*When taken as directed. See Drug Facts Panel.

†This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN® is a registered trademark of Schering Corporation.

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

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

LORATADINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-526
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:68016-526-69	10 in 1 BLISTER PACK
2	NDC:68016-526-31	30 in 1 BLISTER PACK
3	NDC:68016-526-60	60 in 1 BOTTLE
4	NDC:68016-526-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	08/19/2003

Labeler - Premier Value (101668460)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	manufacture(68016-526)

Revised: 07/2012

Document Id: ff6c4d5a-54af-4dde-b50c-feead82efbc8

Set id: 778a6979-ea47-4381-8c40-84b3c2325a7e

Version: 1

Effective Time: 20120720

Premier Value

Daily Med

Current Medication Information

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