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TriLyte: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
420 g/4 L, 5.72 g/4 L, 11.2 g/4 L, 1.48 g/4 L
Other brand names:
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - TriLyte

What is the most important information I should know about TRILYTE?

TRILYTE 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 TRILYTE 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 TRILYTE:

  • vomiting that prevents you from keeping down the solution
  • dizziness
  • urinating less often than normal
  • headache

See Section “What are the possible side effects of TRILYTE” for more information about side effects.

What is TRILYTE?

TRILYTE is a prescription medicine used by adults to clean the colon before a colonoscopy. TRILYTE 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.

TRILYTE is safe and effective for use in pediatric patients aged 6 months and older.

Who should not take TRILYTE?

Do not take TRILYTE 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 TRILYTE. See the end of this leaflet for a complete list of ingredients in TRILYTE.

What should I tell my healthcare provider before taking TRILYTE?

Before you take TRILYTE, 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 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 TRILYTE 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 TRILYTE passes into your breast milk. You and your healthcare provider should decide if you will take TRILYTE while breastfeeding.

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

TRILYTE may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of TRILYTE.

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
  • starch-based thickeners. For patients who have trouble swallowing, do not mix TRILYTE with starch-based thickeners.

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 TRILYTE?

You must read, understand, and follow these instructions to take TRILYTE the right way.

  • Take TRILYTE exactly as your healthcare provider tells you to take it.
  • Drink 240 mL (8 oz.) every 10 minutes. Rapid drinking of each portion is better than drinking small amounts.
  • The first bowel movement should occur approximately one hour after you start drinking the solution.
  • You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, stop drinking temporarily or drink each portion at longer intervals until the discomfort goes away.
  • Continue drinking until the watery stool is clear and free of solid matter. This usually requires 3 liters and it is best to drink all of the solution.
  • Do not take undissolved TRILYTE powder that has not been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration).
  • Each jug of TRILYTE must be reconstituted with water (diluted) to 4 liters total volume before drinking.
  • Do not take other laxatives while taking TRILYTE.

  • Do not eat solid foods on the day before your colonoscopy and until after your colonoscopy. Drink only clear liquids:

    • the day before your colonoscopy
    • while taking TRILYTE
    • after taking TRILYTE until 2 hours before your colonoscopy

What are the possible side effects of TRILYTE?

TRILYTE can cause serious side effects, including:

  • See Section “What is the most important information I should know about TRILYTE?”

  • changes in certain blood tests. Your healthcare provider may do blood tests after you take TRILYTE 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. TRILYTE may cause irregular heartbeats.
  • seizures
  • ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.

The most common side effects of TRILYTE include:

  • nausea
  • stomach (abdominal) fullness
  • bloating
  • stomach (abdominal) cramps
  • vomiting
  • anal irritation

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 TRILYTE. 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 TRILYTE?

  • Store TRILYTE at room temperature, between 15º to 30°C (59º to 86°F).

Keep TRILYTE and all medicines out of the reach of children.

General information about the safe and effective use of TRILYTE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRILYTE for a condition for which it was not prescribed. Do not give TRILYTE 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 TRILYTE. 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876.

What are the ingredients in TRILYTE?

Active ingredients: polyethylene glycol 3350, sodium bicarbonate, sodium chloride, and potassium chloride.

Inactive ingredients: lemon flavor (contains dl-alpha-tocopherol and maltodextrin) and saccharin sodium.

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

Distributed by:

Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 032, India

Revised: 12/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 076491 · View the label on DailyMed

Revision date stated in the text: December 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for TriLyte

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Osmotic Laxative, Potassium Salt
Active ingredients Polyethylene glycol 3350 420 g/4 L, Sodium bicarbonate 5.72 g/4 L, Sodium chloride 11.2 g/4 L, Potassium chloride 1.48 g/4 L
Dosage form Powder, for solution
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) AUROBINDO PHARMA USA
FDA approval ANDA 076491Abbreviated New Drug Application (ANDA) – generic drug Approved February 5, 2004
Therapeutic equivalence (TE) code AACodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics GoLYTELY, Nulytely, Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride, Polyethylene Glycol 3350, Sodium Sulfate, Sodium Bicarbonate, Sodium Chloride, and Potassium Chloride with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
420 g/4 L, 5.72 g/4 L, 11.2 g/4 L, 1.48 g/4 L – 4 l in 1 bottle NDC 84386-013-04

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.