LORATADINE- loratadine tablet
Mylan Pharmaceuticals Inc.

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Drug Facts

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 imprinted foil seal under cap is missing, open or broken.
•: 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?

call 1-877-446-3679

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

PRODUCT PACKAGING

NDC 0378-1925-01

Original Prescription
Strength

Non-Drowsy*

Loratadine
Tablets USP, 10 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

•: Sneezing
•: Runny Nose
•: Itchy, Watery Eyes
•: Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

100 TABLETS

RM1925A3

Loratadine Tablets 10 mg Bottle Front Layer

Loratadine Tablets 10 mg Bottle Back of Front Layer

Loratadine Tablets 10 mg Bottle Base Layer

LORATADINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0378-1925
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (LORATADINE)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
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

#	Item Code	Package Description
Packaging
1	NDC:0378-1925-01	100 in 1 BOTTLE, PLASTIC
2	NDC:0378-1925-05	500 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075790	11/19/2009	02/28/2014

Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 11/2009

Document Id: d1604be0-82cb-4570-a19b-3d25b3bbde14

Set id: cd9f981a-0cdf-48ea-91b7-b5c25632e2c2

Version: 2

Effective Time: 20091118

Mylan Pharmaceuticals Inc.