LORATADINE- loratadine tablet 
Publix Super Markets Inc

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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:

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

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

PRINCIPAL DISPLAY PANEL

Publix

24 - HOUR

allergy relief

LORATADINE TABLETS USP, 10 mg

ANTIHISTAMINE

10 TABLETS

NON-DROWSY*

*When taken as directed.

See Drug Facts Panel.

**Compare to Active Ingredient in Claritin®

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

5084017/0211

This is the 10 count blister carton label for Publix Loratadine tablets, USP 10 mg.
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:56062-526
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
STARCH, PREGELATINIZED CORN 
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-526-6910 in 1 BLISTER PACK
2NDC:56062-526-3130 in 1 BLISTER PACK
3NDC:56062-526-9060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/19/2003
Labeler - Publix Super Markets Inc (006922009)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(56062-526)

Revised: 12/2012
Document Id: fba0b636-da83-40bc-8b42-cac904d65edd
Set id: af62d327-791f-48c1-9200-d49b71558885
Version: 1
Effective Time: 20121227
 
Publix Super Markets Inc