Drug Facts

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

Safety sealed: do not use if the imprinted bottle seal is open or torn.
Store at 20º - 25ºC (68º - 77ºF) (see USP Controlled Room Temperature)..

Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

1-800-525-8747

03-2008M

Sandoz Inc.

Princeton, NJ 08540

PRINCIPAL DISPLAY PANEL

Loratadine Tablets, USP 10mg

Loratadine Tabs USP 10mg Loratadine Tablet, USP 10mg Unit Dose Label

LORATADINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-5586(NDC:0781-5077)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (white to off white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	GG296
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0615-5586-30	6 in 1 BOX, UNIT-DOSE	07/17/2017	11/30/2019
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0615-5586-31	31 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/29/2003	04/30/2020
3	NDC:0615-5586-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/29/2003	04/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075209	01/21/2003	04/30/2020

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Name	Address	ID/FEI	Business Operations
Establishment
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	REPACK(0615-5586)

Revised: 11/2014

Document Id: 3db6caa5-3d67-4e11-b316-a13f1b7d0027

Set id: 27904a98-1393-4968-9c4e-5c9c9ce8bb89

Version: 7

Effective Time: 20141124

NCS HealthCare of KY, Inc dba Vangard Labs