LORATADINE- loratadine tablet 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

For external use only

Do not use

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 room temperature between 15o and 30o C (59o and 86o F). Protect from excessive moisture.

Inactive ingredients

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

Questions?

Adverse drug event, call (800) 616-2471

Principal display panel

Loratadine 10 mg Tablets, USP

Loratadine 10 mg Tablets, USP

LORATADINE 
loratadine tablets tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6074
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, PREGELATINIZED CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint Code rx526
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6074-61100 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34506/15/2010
Labeler - Major Pharmaceuticals (191427277)

Revised: 07/2010
 
Major Pharmaceuticals