SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE (Page 3 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains:

• Two (2) 6 ounce bottles of oral solution.

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

Storage:

Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature.

Keep out of reach of children.

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution Package NDC 40032-700-83

17 PATIENT COUNSELING INFORMATION

See Medication Guide and FDA -Approved Patient Labeling

17.1 Patient Counseling

• Ask patients to let you know if they have trouble swallowing or are prone to regurgitation or aspiration.

• Instruct patients that each bottle needs to be diluted in water before ingestion and that they need to drink additional water according to the instructions. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, and dehydration.

• Inform patients that oral medications may not be absorbed properly if they are taken within one hour of starting each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

• Tell patients not to take other laxatives while they are taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

P17000000104

Rev. 12/2014

Medication Guide

Sodium Sulfate (soe’ dee um sul’ fate), Potassium Sulfate (poe tas’ ee um sul’ fate) and Magnesium Sulfate ( mag nee’ zee um sul’ fate) Oral Solution

Read this Medication Guide before you start taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate oral solution. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and other osmotic bowel preparations can cause serious side effects, including:

Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood.

These changes can cause:

• abnormal heartbeats that can cause death

• seizures. This can happen even if you have never had a seizure.

• kidney problems

Your chance of having fluid loss and changes in body salts with Sodium Sulfate,

Potassium Sulfate and Magnesium Sulfate Oral Solution is higher if you:

• have heart problems
• have kidney problems
• take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Sodium Sulfate,

Potassium Sulfate and Magnesium Sulfate Oral Solution:

• vomiting that prevents you from keeping down the additional prescribed amount of water listed in the Instructions for Use in the Patient Instructions for Use Booklet
• dizziness
• urinating less often than normal
• headache

See Section “What are the possible side effects of Sodium Sulfate, Potassium

Sulfate and Magnesium Sulfate Oral Solution?” for more information about side effects.

What is Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral

Solution?

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is a prescription medicine used by adults to clean the colon before a colonoscopy. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is safe and effective in children

Who should not take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

• Do not take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution if your healthcare provider has told you that you have:
• a blockage in your bowel (obstruction)
• an opening in the wall of your stomach or intestine (bowel perforation)
• problems with food and fluid emptying from your stomach (gastric retention)
• a very dilated intestine (bowel)
• an allergy to any of the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. See the end of this leaflet for a complete list of ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

What should I tell my healthcare provider before taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

Before you take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, tell your healthcare provider if you:

• have heart problems
• have stomach or bowel problems
• have ulcerative colitis
• have problems with swallowing or gastric reflux
• have gout
• have a history of seizures
• are withdrawing from drinking alcohol
• have a low blood salt (sodium) level
• have kidney problems
• any other medical conditions
• are pregnant. It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution passes into your breast milk. You and your healthcare provider should decide if you will take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

Especially tell your healthcare provider if you take:

• medicines for blood pressure or heart problems
• medicines for kidney problems
• medicines for seizures
• water pills (diuretics)
• non-steroidal anti-inflammatory medicines (NSAID) pain medicines
• laxatives

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

See the Instructions for Use in the Patient Instructions for Use Booklet for dosing instructions. You must read, understand, and follow these instructions to take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution the right way.

• Take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution exactly as your healthcare provider tells you to take it.
• Do not drink Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution that has not been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration).
• Each bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution must be mixed with water (diluted) before drinking.
• It is important for you to drink the additional prescribed amount of water listed in the Instructions for Use to prevent fluid loss (dehydration).
• Do not take other laxatives while taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution.
• Do not eat solid foods while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Only clear liquids are allowed while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

What are the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can cause

serious side effects, including:

• See Section “What is the most important information I should know about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?”
• changes in certain blood tests. Your healthcare provider may do blood tests after you take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
• vomiting
• nausea
• bloating
• dizziness
• stomach (abdominal) cramping
• headache
• urinate less than usual
• trouble drinking clear liquid
• heart problems. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may cause irregular heartbeats.
• seizures
• ulcers of the bowel or bowel problems
• worsening gout

The most common side effects of Sodium Sulfate, Potassium Sulfate and Magnesium

Sulfate Oral Solution include:

• discomfort
• bloating
• stomach (abdominal) cramping
• nausea
• vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to

FDA at 1-800-FDA-1088.

How should I store Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

• Store Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution at room temperature, between 59ºF to 86°F (15ºC to 30°C).

Keep Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for a condition for which it was not prescribed. Do not give Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes important information about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

For more information, call 1-866-403-7592

What are the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

Active ingredients: sodium sulfate, potassium sulfate and magnesium sulfate

Inactive ingredients: sodium benzoate, sucralose, malic acid, citric acid, lemon flavor, purified water

Novel Laboratories, Inc.

Somerset, NJ 08873, USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

PI7000000104

Revised 12/2014