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Claritin by Bayer HealthCare LLC.

Medically reviewed on Mar 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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Further information

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

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