Loratadine by Northwind Pharmaceuticals, LLC LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51655-027(NDC:51660-526)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Product Characteristics
Color	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: 51655-027-26	90 in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	10/27/2014

Labeler - Northwind Pharmaceuticals, LLC (036986393)

Registrant - Northwind Pharmaceuticals, LLC (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmaceuticals, LLC		036986393	repack(51655-027)