POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEG-3350 and electrolytes for oral solution, USP

Container Label

label
(click image for full-size original)

Lemon Flavor Pack

lemon flavor pack
(click image for full-size original)
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES
polyethylene glycol-3350 and electrolytes powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-090
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 236 g in 274.31 g
SODIUM SULFATE ANHYDROUS (SODIUM SULFATE ANHYDROUS) SODIUM SULFATE ANHYDROUS 22.74 g in 274.31 g
SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE 6.74 g in 274.31 g
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 5.86 g in 274.31 g
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 2.97 g in 274.31 g
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM
MALTODEXTRIN
Product Characteristics
Color Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-090-19 274.31 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090231 06/01/2009
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 MANUFACTURE (40032-090), ANALYSIS (40032-090), PACK (40032-090)

Revised: 12/2016 Novel Laboratories, Inc.

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