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Loratadine by Innovative Manufacturing and Distribution Services, Inc.

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Innovative Manufacturing and Distribution Services, Inc.
NDC Code: 59564-251

Drug Facts

Active ingredient

Loratadine 10mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

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
  • side effects occur.

You may report side effects to FDA at 1-800-FDA-1088.

If pregnant or breastfeeding

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 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
  • Safety sealed: do not use if the imprinted bottle seal is open or torn
  • Store at 15° - 30° C (59° - 86° F).

Inactive ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Package/Label Principal Display Panel

IMDS INC.

Loratadine

(Compare to Claritin®)

30 TABLETS

10 mg

Relief of: Sneezing, Runny Nose,

Itchy Watery Eyes, Itchy Throat or Nose

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59564-251
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeRX526
Contains    
Packaging
#Item CodePackage Description
1NDC:59564-251-1030 TABLET (TABLET) in 1 BOTTLE
2NDC:59564-251-30100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613412/01/2008
Labeler - Innovative Manufacturing and Distribution Services, Inc. (794520429)
Establishment
NameAddressID/FEIOperations
Innovative Manufacturing and Distribution Services, Inc.794520429REPACK

 
Innovative Manufacturing and Distribution Services, Inc.

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Medically reviewed on Aug 6, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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