LORATADINEANTIHISTAMINE ANTIHISTAMINE- loratadine tablet 
REMEDYREPACK INC.

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Perrigo Loratadine Tablets, 10 mg Drug Facts

OTC - ACTIVE INGREDIENT

Loratadine 10 mg

 

OTC - PURPOSE

Antihistamine

 

INDICATIONS & USAGE

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

 

WARNINGS

if you have ever had an allergic reaction to this product or any of its ingredients

 

liver or kidney disease. Your doctor should determine if you need a different dose.

 

do not take more than directed. Taking more than directed may cause drowsiness.

 

an allergic reaction to this product occurs. Seek medical help right away.

 

ask a health professional before use.

 

In case of overdose, get medical help or contact a Poison Control Center right away.

 

DOSAGE & ADMINISTRATION

adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

 

STORAGE AND HANDLING

 

INACTIVE INGREDIENT

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

 

OTC - QUESTIONS

1-800-719-9260

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Loratadineantihistamine antihistamine


GENERIC: Loratadine


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 49349-218-20


ACTIVE INGREDIENT(S):


INACTIVE INGREDIENT(S):


COLOR: white


SHAPE: OVAL


SCORE: No score


SIZE: 8 mm


IMPRINT: L612


PACKAGING: 100 in 1 VIAL



MM1

MM2

LORATADINEANTIHISTAMINE  ANTIHISTAMINE
loratadine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49349-218(NDC:45802-650)
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)  
POVIDONE (UNII: FZ989GH94E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (TABLET) Size8mm
FlavorImprint Code L612
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-218-20100 in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630105/20/2013
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2013
Document Id: 40edf56f-dd24-41e0-8002-986e2fd1e0a5
Set id: fa5ddd82-33ba-4cc8-a13f-1a866299367e
Version: 1
Effective Time: 20130520
 
REMEDYREPACK INC.