LORATADINE - loratadine tablet 
International Labs, Inc.

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Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

Temporarily relieves the symptoms due to hay fever or other upper respiratory allergies:

WARNINGS

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.



Keep Out of Reach of Children Section

In case of overdose, get medical help or contat a Poison Control Center right away.

DOSAGE & ADMINISTRATION

 Loratadine Table 1

Loratadine Table 1

DIRECTIONS

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

Other Information


INACTIVE INGREDIENTS

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

LORATADINE TABLETS, USP 10 mg - Label

LB0092 - Loratadine Tablets, USP 10 mg

Shellpack Label



LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54458-942(NDC:60505-0147)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITE (off white) Score no score
ShapeOVALSize8mm
FlavorImprint Code APO;LOR;10
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54458-942-1030 TABLET (30 TABLET) in 1 BLISTER PACKNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647107/13/200910/28/2011

Labeler - International Labs, Inc. (023569924)
Establishment
NameAddressID/FEIOperations
International Labs, Inc.023569924RELABEL, REPACK

Revised: 02/2012 International Labs, Inc.