Active ingredient

Loratadine USP, 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: · itching of the nose or throat · runny nose · itchy, watery eyes · sneezing

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 thsi 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.

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

call 1-800-406-7984

†This product is not manufactured or distributed by Schering-Plough Healthcare Products Inc., owner of the registered trademark Claritin®.

Manufactured by
Ohm Laboratories, Inc.
North Brunswick, NJ 08902

Repackaged by
Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

LORATADINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	21695-499 (51660-526)
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, CORN

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	RX;526
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	21695-499-15	15 TABLET In 1 BOTTLE	None
2	21695-499-20	20 TABLET In 1 BOTTLE	None
3	21695-499-30	30 TABLET In 1 BOTTLE	None
4	21695-499-72	120 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/21/2010

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK

Revised: 02/2011Rebel Distributors Corp