NDC Code(s) : 11523-4360-5, 11523-4360-2, 11523-4360-6, 11523-4360-4, 11523-4360-7, 11523-4360-3, 11523-4360-1
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Children Claritin loratadine SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-4360
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE(UNII: 7AJO3BO7QN)
(LORATADINE - UNII:7AJO3BO7QN) 		LORATADINE5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11523-4360-51 in 1 CARTON 26/05/2015
1240 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:11523-4360-21 in 1 CARTON 25/09/2015
2120 mL in 1 BOTTLE Type 0: Not a Combination Product
3NDC:11523-4360-61 in 1 CARTON 10/05/2015
3180 mL in 1 BOTTLE Type 0: Not a Combination Product
4NDC:11523-4360-41 in 1 CARTON 11/01/2015
430 mL in 1 BOTTLE Type 0: Not a Combination Product
5NDC:11523-4360-72 in 1 CARTON 03/01/2016
5180 mL in 1 BOTTLE Type 0: Not a Combination Product
6NDC:11523-4360-31 in 1 CARTON 01/01/2016
6150 mL in 1 BOTTLE Type 0: Not a Combination Product
7NDC:11523-4360-11 in 1 CARTON 26/05/2015
760 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020641 05/26/2015

LABELER - Bayer HealthCare LLC.(112117283)

PRINCIPAL DISPLAY PANEL

4 oz. carton label