Levocetirizine Dihydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2836(NDC:31722-659)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE) LEVOCETIRIZINE DIHYDROCHLORIDE 2.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
MALTITOL
METHYLPARABEN
PROPYLPARABEN
WATER
SODIUM ACETATE
ACETIC ACID
SACCHARIN SODIUM
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2836-8 1 BOTTLE in 1 CARTON contains a BOTTLE
1 148 mL in 1 BOTTLE This package is contained within the CARTON (68071-2836-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210914 04/01/2019
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-2836)

Revised: 12/2022 NuCare Pharmaceuticals,Inc.

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