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Loratadine by Innovative Manufacturing and Distribution Services, Inc.

Medically reviewed on August 7, 2017

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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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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