LORATADINE- loratadine tablet 
Major Pharmaceuticals

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Loratadine tablets

Active ingredient

Loratidine USP 10 mg

Purpose

Antihistamine

Use

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies, runny nose, itchy, watery eyes, sneezing, itching of the nose and throat.

Warning

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. You doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

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.

Pregnancy/breast-feeding warning

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 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

Store at 20º - 25ºC (68º -77ºF); excursions permitted to 15o - 30o C (59o - 86o F). [ See USP Controlled Room Temperature]

Protect from excessive moisture.

Inactive ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions?

Questions or comments? (800) 616-2471

Distributed by:

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI  48150 USA

Re-Order No. 301592

PRINCIPAL DISPLAY PANEL LORATADINE TABLETS, USP 10MG

 LORATADINE TABLETS, USP 10MG

LORATADINE 
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6074(NDC:51660-526)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code rx526
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-6074-61 100 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076134 06/15/2010
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2012
Document Id: 240ff2a7-7493-4d90-ac7a-c4885f7899a3
Set id: dece3618-cc76-4f43-8e0f-25da104fdb54
Version: 18
Effective Time: 20121017
 
Major Pharmaceuticals