CLARITIN- loratadine tablet, chewable 
Bayer HealthCare LLC.

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Children's Claritin Chewable

Drug Facts

Active Ingredients

Loratadine 5 mg

Purpose

Antihistamine

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

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

AS a doctor before use if you have

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

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

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

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

chew 2 tablets daily; not more than 2 tablets in 24 hours

children 2 to under 6 years of age

chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

1-800-CLARITIN

ages

2 years®

and older

Children's

Claritin®

Chewables

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel

Non-Drowsy*

24 Hour Relief of:

Bubblegum

Flavored

10

Chewable Tablets

10-count carton

CLARITIN 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4330
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ASPARTAME (UNII: Z0H242BBR1)  
Product Characteristics
Colorpink (Light to Medium Pink with a Slightly and/or Mottled Appearance) Scoreno score
ShapeROUND (Round (Flat Faced Beveled Edge)) Size10mm
FlavorBUBBLE GUMImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-4330-11 in 1 CARTON09/25/2015
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-4330-33 in 1 CARTON09/25/2015
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:11523-4330-44 in 1 CARTON09/25/2015
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02189109/25/2015
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 10/2022
Document Id: eb00777b-2fef-e655-e053-2995a90a3846
Set id: 20938e05-bc3e-51aa-e054-00144ff88e88
Version: 7
Effective Time: 20221014
 
Bayer HealthCare LLC.