LORATADINE- loratadine tablet 
Northstar RxLLC

----------

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:

•
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.

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

•
Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
•
Safety sealed: do not use if open or torn (for blister package only).

•
Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

1-800-206-7821

© 2005 NorthStar Healthcare Holdings     I10-2015M

Manufactured for: Northstar Rx LLC

Memphis, TN 38141.

Manufactured by: Sandoz Inc.

Princeton, NJ 08540.

10 mg Label

Loratadine 10 mg Label

NDC 16714-482-01

Non-Drowsy*

Loratadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

30 Tablets

NORTHSTAR™

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16714-482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code GG296
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16714-482-0130 in 1 BOTTLE; Type 0: Not a Combination Product02/01/201609/30/2020
2NDC:16714-482-02100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/201610/31/2020
3NDC:16714-482-03300 in 1 BOTTLE; Type 0: Not a Combination Product02/01/201612/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520902/01/201612/31/2020
Labeler - Northstar RxLLC (830546433)

Revised: 2/2019
Document Id: f6946e6a-bff4-4115-9f0f-d4734d769151
Set id: a3816d0d-e211-4a31-9317-86ec315f2669
Version: 12
Effective Time: 20190215
 
Northstar RxLLC