NDC Code(s) : 51672-4070-8
Packager : Taro Pharmaceuticals U.S.A., Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cetirizine HydrochlorideCetirizine Hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4070
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE(UNII: 64O047KTOA)
(CETIRIZINE - UNII:YO7261ME24) 		CETIRIZINE HYDROCHLORIDE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM ACETATE ANHYDROUS(UNII: NVG71ZZ7P0)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color yellow (colorless to slightly yellow) Score
Shape Size
Flavor GRAPE, BANANA Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51672-4070-81 in 1 CARTON 05/01/2014
1120 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
ANDA ANDA076601 05/01/2014

LABELER - Taro Pharmaceuticals U.S.A., Inc.(145186370)

Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceutical Industries Ltd. 600072078 manufacture(51672-4070)

PRINCIPAL DISPLAY PANEL

cetirizine-02NDC 51672-4070-8

120 mL

Cetirizine
Hydrochloride
Oral Solution
USP,
1 mg/mL*

FOR ORAL USE ONLY

Rx only
TARO