SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

NDC 40032-700-02

Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral Solution

17.5 g/3.13 g/1.6 g per 6 ounces

Dispense the enclosed Medication Guide to each patient.

This bottle contains 6 ounces (177 mL) of solution

Directions:

Dilute the solution concentrate prior to use. See enclosed booklet for complete dosage and administration instructions. Both 6-ounce bottles are required for a complete prep.

Keep this and other drugs out of reach of children. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Carton Label

NDC 40032-700-83

Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral Solution

17.5 g/3.13 g/1.6 g per 6 ounces

This carton contains:

2 6-ounce (177 mL) bottles of solution

(1 )19 ounce mixing container with a 16 ounce fill line.

Booklet includes:

1- Medication Guide3

2- Patient Instructions

3- Full Prescribing Information

Dilute the solution concentrate as directed prior to use.

Both 6-ounce bottles are required for a complete prep.

Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).

RX only

Panel 1 and 2

Panel 3 and 4

Carton

NDC 40032-700-83

Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral Solution

17.5 g/3.13 g/1.6 g per 6 ounces

Dispense the enclosed Medication Guide to each patient.

This carton contains 2 6- ounce bottles of liquid bowel prep; and

1 16- ounce mixing container.

Directions:

Dilute the solution concentrate prior to use. See enclosed booklet for complete dosage and administration instructions. Both 6-ounce bottles are required for a complete prep.

Keep this and other drugs out of reach of children. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE sodium sulfate, potassium sulfate, magnesium sulfate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-700 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM SULFATE (SODIUM SULFATE ANHYDROUS) SODIUM SULFATE 17.5 g in 177 mL POTASSIUM SULFATE (SULFATE ION) POTASSIUM SULFATE 3.13 g in 177 mL MAGNESIUM SULFATE ANHYDROUS (MAGNESIUM CATION) MAGNESIUM SULFATE ANHYDROUS 1.6 g in 177 mL

Inactive Ingredients Ingredient Name Strength MALIC ACID ANHYDROUS CITRIC ACID SODIUM BENZOATE WATER SUCRALOSE

Product Characteristics Color Score Shape Size Flavor LEMON Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:40032-700-83 2 BOTTLE in 1 CARTON contains a BOTTLE 1 177 mL in 1 BOTTLE This package is contained within the CARTON (40032-700-83)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202511 02/23/2017

Labeler — Novel Laboratories, Inc. (793518643)

Registrant — Novel Laboratories, Inc. (793518643)

Establishment
Name	Address	ID/FEI	Operations
Novel Laboratories, Inc.		793518643	ANALYSIS (40032-700), MANUFACTURE (40032-700), PACK (40032-700)

Revised: 12/2017 Novel Laboratories, Inc.