Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate (Page 2 of 2)

HOW SUPPLIED

PEG 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE with Flavor Pack is supplied in a disposable jug, in powdered form, for oral administration as a solution following reconstitution. Each jug has an attached lemon flavor pack, in powdered form, for the addition of the flavor pack by the pharmacist prior to dispensing.

PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND SODIUM BICARBONATE FOR ORAL SOLUTION with Flavor Pack: PEG 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and lemon flavor pack 2 g (optional). When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

STORAGE: Store in sealed container at 25°C. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

NDC 40032-050-19

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE
polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-050
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 420 g in 438.4 g
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 11.2 g in 438.4 g
SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE 5.72 g in 438.4 g
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 1.48 g in 438.4 g
Inactive Ingredients
Ingredient Name Strength
ALPHA-TOCOPHEROL, DL-
SACCHARIN SODIUM
MALTODEXTRIN
ACACIA
Product Characteristics
Color Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-050-19 438.4 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090019 05/28/2009
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 MANUFACTURE, REPACK
Establishment
Name Address ID/FEI Operations
Dow Chemical Company 801038019 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Mallinckrodt Baker Inc. 001213481 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Church and Dwight Co, Inc. 001211952 API MANUFACTURE

Revised: 05/2009 Novel Laboratories, Inc.

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