PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID - peg-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid 
Teva Pharmaceuticals USA, Inc.

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MEDICATION GUIDE

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution

(pol˝ ee eth´ i leen glye´ kol, soeˊ dee um sul' fate, soeˊ dee um klor´ ide, poe tasˊee um klor´ ide,    soeˊ dee um a skor´ bate, as koreˊ bik as´ id for oral solution)

Read this Medication Guide and Instructions for Use before your colonoscopy and again before you start taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.

What is the most important information I should know about PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution? PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution and other bowel preparations can cause serious side effects, including:

Your chance of having fluid loss and changes in body salts with PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is higher if you:

Tell your healthcare provider right away if you have any of these symptoms of serious loss of body fluid (dehydration) while taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution:

See "What are the possible side effects of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?" for more information about side effects.

What is PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is a prescription medicine used by adults to clean the colon before a colonoscopy. PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

It is not known if PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is safe and effective in children

Who should not take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

Do not take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution if your healthcare provider has told you that you have:

What should I tell my healthcare provider before taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

Before taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:

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

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution may affect how other medicines work. Do not take medicines by mouth 1 hour before or after the start of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.

Especially tell your healthcare provider if you take:

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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

See the "Instructions for Use" for dosing instructions. You must read, understand, and follow these instructions to take PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution the right way. 

What are the possible side effects of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution? PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution can cause serious side effects, including:

The most common side effects of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution include:

These are not all the possible side effects of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.

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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution?

Keep PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution for a condition for which it was not prescribed. Do not give PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for 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 the most important information about PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for 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 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution?

Active ingredients:

Pouch A: polyethylene glycol (PEG) 3350, sodium sulfate, sodium chloride, potassium chloride.

Pouch B: ascorbic acid and sodium ascorbate.

Inactive ingredients:

Lemon Flavor Pack: Natural lemon flavor, maltodextrin and Saccharin Sodium.

Distributed By:

Teva Pharmaceuticals USA, Inc

North Wales, PA 19454

 

PI0402604001

Iss.03/2019

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

Issued: March 2019.

Revised: 8/2020
Teva Pharmaceuticals USA, Inc.