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Loratadine by NCS HealthCare of KY, Inc dba Vangard Labs

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-5586

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.
  • Store at 20º - 25ºC (68º - 77ºF) (see USP Controlled Room Temperature)..

Inactive Ingredients

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

Questions or comments?

1-800-525-8747

03-2008M

Sandoz Inc.

Princeton, NJ 08540

PRINCIPAL DISPLAY PANEL

Loratadine Tablets, USP 10mg

 

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-5586(NDC:0781-5077)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeGG296
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-5586-306 BLISTER PACK in 1 BOX, UNIT-DOSE
15 TABLET in 1 BLISTER PACK
2NDC:0615-5586-3131 TABLET in 1 BLISTER PACK
3NDC:0615-5586-3930 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520901/21/2003
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943REPACK(0615-5586)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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Medically reviewed on Nov 26, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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