LORATADINE- loratadine tablet 
American Health Packaging

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredient

Loratadine USP, 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: · itching of the nose or throat · runny nose · itchy, watery eyes · sneezing

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 thsi 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 ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

store between 20 and 25°C (68 and 77°F) · protect from excessive moisture.

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

call 1-800-406-7984

†This product is not manufactured or distributed by Schering-Plough Healthcare Products Inc., owner of the registered trademark Claritin®.

Manufactured by
Ohm Laboratories, Inc.
North Brunswick, NJ 08902

Repackaged by
American Health Packaging
Columbus, Ohio 43217

Package/Label Principal Display Panel

Loratadine 10 mg Label
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-248(NDC:51660-526)
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, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint Code RX;526
Contains    
Packaging
#Item CodePackage Description
1NDC:68084-248-0110 in 1 CARTON
1NDC:68084-248-1110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/21/2010
Labeler - American Health Packaging (007914906)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging007914906REPACK
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories051565745MANUFACTURE

Revised: 01/2010
Document Id: 411f3692-99ff-49d7-8594-e6f404f5861f
Set id: 411f3692-99ff-49d7-8594-e6f404f5861f
Version: 1
Effective Time: 20100121
 
American Health Packaging