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 Type HUMAN OTC DRUG Item Code (Source) NDC:56062-526
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color white (White to Off-White) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RX526
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-526-69 10 in 1 BLISTER PACK
2 NDC:56062-526-31 30 in 1 BLISTER PACK
3 NDC:56062-526-90 60 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076134 08/19/2003
Labeler - Publix Super Markets Inc (006922009)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(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