LORATADINE ALLERGY RELIEF- loratadine tablet 
TYA Pharmaceuticals

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Drug Facts

ACTIVE INGREDIENT(S)

Loratadine USP, 10 mg

PURPOSE

Antihistamine

USE(S)

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

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

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

LORATADINE ALLERGY RELIEF (LORATADINE) TABLET

Label Image
LORATADINE ALLERGY RELIEF 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-0526(NDC:51660-526)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (White to Off White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64725-0526-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/28/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/28/2003
Labeler - TYA Pharmaceuticals (938389038)
Registrant - TYA Pharmaceuticals (938389038)
Establishment
NameAddressID/FEIBusiness Operations
TYA Pharmaceuticals938389038RELABEL(64725-0526) , REPACK(64725-0526)

Revised: 6/2012
Document Id: 97284b19-ca6f-4ec0-adbc-b0720cec7e49
Set id: ff1b0b4e-f74f-451d-8d13-4fa707727547
Version: 3
Effective Time: 20120618
 
TYA Pharmaceuticals