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Claritin by Bayer HealthCare LLC.

Medically reviewed on March 29, 2018

Dosage form: tablet, chewable
Ingredients: LORATADINE 5mg
Labeler: Bayer HealthCare LLC.
NDC Code: 11523-4328

Claritin ®

Active ingredient (in each tablet)

Loratadine 5 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, 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 overchew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of agechew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information
  • phenylketonurics: contains phenylalanine 1.4 mg per tablet
  • safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Dist by: Bayer HealthCare LLC, Whippany, NJ 07981

Product of Ireland

PRINCIPAL DISPLAY PANEL - 10 Chewable Tablet Blister Pack Carton

NDC 11523-4328-1

ages

2 years

and older

Children's

Claritin®

Allergy

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

Non-Drowsy*

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

10 CHEWABLE TABLETS

Grape

Flavored

Chewables

*When taken as directed. See Drug Facts Panel.

CLARITIN 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4328
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
ANHYDROUS CITRIC ACID 
SILICON DIOXIDE 
D&C RED NO. 27 
FD&C BLUE NO. 2 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
Colorpurple (light to medium purple with a slightly speckled and/or mottled appearance) Scoreno score
ShapeROUND (flat faced beveled edge) Size10mm
FlavorGRAPEImprint CodeC
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-4328-11 BLISTER PACK in 1 CARTON
110 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:11523-4328-22 BLISTER PACK in 1 CARTON
210 TABLET, CHEWABLE in 1 BLISTER PACK
3NDC:11523-4328-33 BLISTER PACK in 1 CARTON
310 TABLET, CHEWABLE in 1 BLISTER PACK
4NDC:11523-4328-55 BLISTER PACK in 1 CARTON
410 TABLET, CHEWABLE in 1 BLISTER PACK
5NDC:11523-4328-41 BLISTER PACK in 1 POUCH
52 TABLET, CHEWABLE in 1 BLISTER PACK
6NDC:11523-4328-72.5 BLISTER PACK in 1 PACKAGE, COMBINATION
610 TABLET, CHEWABLE in 1 BLISTER PACK
7NDC:11523-4328-94 BLISTER PACK in 1 CARTON
710 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02189108/23/2006
CLARITIN 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4331
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
SILICON DIOXIDE 
MANNITOL 
MAGNESIUM STEARATE 
ASPARTAME 
FD&C BLUE NO. 2 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
D&C RED NO. 27 
STEARIC ACID 
ALUMINUM OXIDE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colorpurple (Light to medium purple with a slightly speckled and/or mottled appearance) Scoreno score
ShapeROUND (Flat Faced Beveled Edge) Size10mm
FlavorGRAPEImprint CodeC
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-4331-14 BLISTER PACK in 1 CARTON
110 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02189108/23/2006
Labeler - Bayer HealthCare LLC. (112117283)

 
Bayer HealthCare LLC.

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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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