LORATADINE- loratadine tablet 
Northwind Pharmaceuticals, LLC

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Loratadine

PURPOSE

Antihistamine

USE(S)

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.

QUESTIONS

Call 1-800-406-7984

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-027-26

MFG: 51660-526-05

Loratadine 10 MG

90 Tablets

Rx Only

Lot#

Exp. Date:

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dosage: See prescriber's instructions

Each tablet contains 10 mg of loratadine

Store at 68 to 77 degrees F.

Protect from light and moisture

Keep out of the reach of children.

Mfg. by Ohm Laboratories, North Brunswick, NJ 08902 Lot#

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

51655-027-26

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-027(NDC:51660-526)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51655-027-2690 in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613410/27/2014
Labeler - Northwind Pharmaceuticals, LLC (036986393)
Registrant - Northwind Pharmaceuticals, LLC (036986393)
Establishment
NameAddressID/FEIBusiness Operations
Northwind Pharmaceuticals, LLC036986393repack(51655-027)

Revised: 10/2014
Document Id: 0f7228b0-773b-4355-b439-b6b6f5bd1659
Set id: c45c1dba-ba6c-4dfb-a1ee-c5ec61ad4dfb
Version: 1
Effective Time: 20141031
 
Northwind Pharmaceuticals, LLC