Active ingredient

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° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.

Questions or comments?

1-800-848-0462

Serious side effects associated with use of this product may be reported to this number.

How Supplied:

Loratidine Tablets, USP are available as follows:

10 mg - White to off-white, round, flat-faced, beveled edge, unscored tablet debossed with M on one side and L over 17 on the other side.

NDC 51079-538-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).

Store between 20° to 25°C (68° to 77°F). Protect from excessive moisture.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

Packaged and Distributed by:
UDL Laboratories, Inc.
Rockford, IL 61103

S-10314
11/08

Principal Display Panel

Loratadine Tablets, USP

10 mg

Antihistamine

10 Tablets

LORATADINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-5099(NDC:51079-538)
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SODIUM LAURYL SULFATE

Product Characteristics
Color	WHITE (white to off-white)	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	M;L;17
Contains

Packaging
#	Item Code	Package Description
1	NDC:55154-5099-0	10 in 1 BAG
1		1 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075790	11/19/2009

Labeler - Cardinal Health (188557102)

Establishment
Name	Address	ID/FEI	Business Operations
Cardinal Health		188557102	REPACK(55154-5099)

Revised: 04/2012

Document Id: 0bada555-79ef-4fbf-ab7b-dac892e8e0af

Set id: ed094283-40b0-49aa-bbe7-58c6405b1bf0

Version: 3

Effective Time: 20120424

Cardinal Health