CHILDREN CLARITIN ALLERGY- loratadine solution 
Bayer HealthCare LLC.

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Children's Claritin Allergy (Grape Flavor)

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

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

Use only with enclosed dosing cup

edetate disodium, flavor, glycerin, maltitol, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

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

4 oz. carton label

CHILDREN CLARITIN  ALLERGY
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4360
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MALTITOL (UNII: D65DG142WK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-4360-51 in 1 CARTON05/26/2015
1240 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:11523-4360-21 in 1 CARTON09/25/2015
2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:11523-4360-61 in 1 CARTON10/05/2015
3180 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:11523-4360-41 in 1 CARTON11/01/2015
430 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:11523-4360-72 in 1 CARTON03/01/2016
5180 mL in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:11523-4360-31 in 1 CARTON01/01/2016
6150 mL in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:11523-4360-11 in 1 CARTON05/26/2015
760 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02064105/26/2015
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 11/2023
Document Id: 0b61ba97-533d-90f2-e063-6394a90a4801
Set id: 170061e9-e529-4ff0-e054-00144ff8d46c
Version: 16
Effective Time: 20231130
 
Bayer HealthCare LLC.