CLARITIN- loratadine tablet, chewable 
Bayer HealthCare LLC.

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Claritin ® Chewables

Active ingredient (in each tablet)

Loratadine 5 mg

Purpose

Antihistamine

Uses

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

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

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:

10 CHEWABLE TABLETS

Grape

Flavored

Chewables

*When taken as directed. See Drug Facts Panel.

Carton

Carton 2

CLARITIN 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4328
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
ASPARTAME (UNII: Z0H242BBR1)  
Product Characteristics
Colorpurple (light to medium purple with a slightly speckled and/or mottled appearance) Scoreno score
ShapeROUND (flat faced beveled edge) Size10mm
FlavorGRAPEImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-4328-11 in 1 CARTON08/23/2006
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-4328-22 in 1 CARTON08/23/2006
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:11523-4328-33 in 1 CARTON08/23/2006
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:11523-4328-55 in 1 CARTON08/23/2006
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:11523-4328-41 in 1 POUCH08/23/2006
52 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:11523-4328-72.5 in 1 PACKAGE, COMBINATION08/23/2006
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:11523-4328-94 in 1 CARTON08/23/2006
710 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:11523-4328-650 in 1 BOX08/23/2006
82 in 1 POUCH; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MANNITOL (UNII: 3OWL53L36A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ASPARTAME (UNII: Z0H242BBR1)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Colorpurple (Light to medium purple with a slightly speckled and/or mottled appearance) Scoreno score
ShapeROUND (Flat Faced Beveled Edge) Size10mm
FlavorGRAPEImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-4331-14 in 1 CARTON08/23/2006
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-4331-26 in 1 CARTON09/06/2019
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:11523-4331-68 in 1 CARTON08/23/2006
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02189108/23/2006
Labeler - Bayer HealthCare LLC. (112117283)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Manufacturing Services LLC079415560manufacture(11523-4328)

Revised: 6/2023
Document Id: ff32e332-882f-e529-e053-6394a90acd5d
Set id: 37732ca2-b454-4215-91a2-c62e0f7a56af
Version: 13
Effective Time: 20230628
 
Bayer HealthCare LLC.