Active ingredient (in each tablet)

Loratadine USP, 10mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other 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.

If pregnant or breast feeding, ask a health professional before use.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

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

see side panel for lot number and expiration date
store between 20 and 25 degrees C (68 and 77 degrees F)
protect from excessive moisture

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions or Comments? 1-800-858-3889

Package Label

BACTIMICINA ALLERGY
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	24286-1549
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	Score	no score
Shape	ROUND (RX526)	Size	7mm
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	24286-1549-2	2 BLISTER In 1 BOX	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	10/21/2009

Labeler - DLC Laboratories, Inc. (093351930)

Establishment
Name	Address	ID/FEI	Operations
OHM Pharmaceuticals		051565745	manufacture

Establishment
Name	Address	ID/FEI	Operations
DLC Laboratories, Inc.		093351930	relabel

Revised: 10/2009DLC Laboratories, Inc.