Loratadine

LORATADINE- loratadine tablet
Northwind Pharmaceuticals, LLC

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
(click image for full-size original)
LORATADINE
loratadine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-027(NDC:51660-526)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RX526
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-027-26 90 TABLET in 1 BOTTLE, DISPENSING None
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 Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-027)

Revised: 10/2014 Northwind Pharmaceuticals, LLC

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