Your browser does not support JavaScript! LORATADINE TABLET [MAJOR PHARMACEUTICALS]
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RxNorm Names

LORATADINE tablet
[Major Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0904-6074(NDC:51660-526)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint Code rx526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6074-61100 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613406/15/2010
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2012
 
Major Pharmaceuticals

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