Now, less is an option.

Introducing GaviLyte™-H, generic of HalfLytely®*
(PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet)
the newest addition to the GaviLyte family.



  • GaviLyte™-H

    generic of HalfLytely®*


    (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet)


    GaviLyte-H compares to HalfLytely®* and is indicated for bowel cleansing prior to colonoscopy. GaviLyte-H is contraindicated in patients with gastrointestinal obstruction, gastric retention, bowel perforation and other conditions. Click here to View Important Safety Information.

    Package contents:
    • 2-liter container
    • Flavor packs - Orange, Lemon and Cherry
    • GaviLyte-H powder
    • Bisacodyl DR tablet



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    GaviLyte-H 2 liter container with bisacodyl tablet and flavor packs



    Step by Step

    GaviLyte™-H
    (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet)


    Take one 5mg bisacodyl delayed-release tablet with water. Do NOT chew or crush the tablet.


    Tear open one Flavor Pack of choice and pour into GaviLyte-H bottle. Discard unused packs. Prepare the solution by filling the container to the 2L mark with lukewarm drinking water.

    Make sure to fill all the way to the FILL LINE.


    Cap the container. Shake vigorously to dissolve the powder. If desired, refrigerate the solution before drinking. (Refrigerated bowel prep is not recommended for children.)


    Wait for a bowel movement (or maximum of 6 hours) then drink the 2L solution at a rate of 8 ounces every 10 minutes. Drink all the solution.


    Tips for Effective Use


    No solid food or milk (clear liquids only) should be consumed on the day of the preparation.

    No antacids should be taken within one hour of taking the bisacodyl delayed-release tablet.

    If abdominal distention or discomfort occurs, stop drinking the solution temporarily or drink each portion at longer intervals until symptoms improve.

    Consume only clear liquids after taking the solution until the colonoscopy is completed.






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  • GaviLyte™-C

    generic of CoLyte®*


    (PEG-3350, sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride )

    GaviLyte-C, PEG-3350 and Electrolytes for Oral Solution, is an effective bowel prep kit used prior to colonoscopy or barium enema X-ray examination. Click here to View Important Safety Information.



    Package contents:
    • 4-liter container
    • Flavor pack
    • GaviLyte-C powder



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    GaviLyte-C 4 liter container with flavor pack

    Step by Step

    GaviLyte™-C
    (PEG-3350, sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride)


    If choosing to add provided flavoring, add the lemon flavor pack to the GaviLyte-C powder in the 4L container before reconstituting and shake well to incorporate flavoring into the powder.


    Add lukewarm drinking water up to the fill line mark on the bottle. Solution should be 4L upon reconstitution.

    TIP: Make sure to fill all the way to the fill line.



    Cap bottle securely and shake vigorously to dissolve ingredients.


    Adults should drink one 8-ounce (240mL) cup of solution rapidly every 10 minutes until the watery stool is clear and free of solid matter. This is usually complete after drinking 3L to 4L. Rapid drinking of each portion is preferred to drinking small amounts continuously. The first bowel movement should commence in approximately one hour.


    Tips for Effective Use


    Patients should not have solid food for at least 2 hours before solution is given. Ideally, the patient should fast 3-4 hours prior to GaviLyte-C administration.

    Lukewarm water facilitates dissolution.

    The solution is more palatable if chilled before drinking. However, chilled solution is not recommended for infants.

    GaviLyte-C should be used within 48 hours of reconstituting. Discard any solution that is not used within that time frame.





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  • GaviLyte™-N

    generic of NuLytely®*


    (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride)

    GaviLyte-N, PEG-3350 and Electrolytes for Oral Solution, is an effective bowel prep kit used prior to colonoscopy. Click here to View Important Safety information.

    Package contents:
    • 4-liter container
    • Flavor pack
    • GaviLyte-N powder



    page


    GaviLyte-N 4 liter container with flavor pack

    Step by Step

    GaviLyte™-N
    (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride)


    Add GaviLyte-N powder and lukewarm drinking water up to the fill mark on the bottle. Solution should be 4L upon reconstitution.

    TIP: Make sure to fill all the way to the fill line.

    Cap bottle securely and shake vigorously to dissolve ingredients.


    Adults

    should drink one 8-ounce (240mL) cup of solution rapidly every 10 minutes until the watery stool is clear and free of solid matter. This typically requires at least 3L of solution. Rapid drinking of each portion is preferred to drinking small amounts continuously.


    Pediatrics
    (6 months or older)


    should drink 25mL/kg per hour until watery stool is clear and free of solid matter. Rapid drinking of each portion is preferred to drinking small amounts continuously.


    The first bowel movement should commence in approximately one hour.


    Tips for Effective Use


    Patients should not have solid food for at least 2 hours before solution is given. Ideally, the patient should fast 3-4 hours prior to GaviLyte-N administration.

    The solution is more palatable if chilled before drinking. However, chilled solution is not recommended for infants.

    GaviLyte-N should be used within 48 hours of reconstituting. Discard any solution that is not used within that time frame.




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  • GaviLyte™-G

    generic of GoLytely®*


    (PEG-3350, sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride)

    GaviLyte-G, PEG-3350 and Electrolytes for Oral Solution, is an effective bowel prep kit used prior to colonoscopy or barium enema X-ray examination. Click here to View Important Safety Information.



    Package contents:
    • 4-liter container
    • Optional lemon flavor pack
    • GaviLyte-G powder



    page


    GaviLyte-G 4 liter container with flavor pack

    Step by Step

    GaviLyte™-G
    (PEG-3350, sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride)


    Add GaviLyte-G powder and lukewarm drinking water up to the fill line mark on the bottle. Solution should be 4L upon reconstitution.

    TIP: Make sure to fill all the way to the fill line.


    Cap bottle securely and shake vigorously to dissolve ingredients.


    Adults should drink one 8-ounce (240mL) cup of solution rapidly every 10 minutes until the watery stool is clear and free of solid matter (or until 4L is consumed). Rapid drinking of each portion is preferred to drinking small amounts continuously.


    The first bowel movement should commence in approximately one hour.


    Tips for Effective Use


    Patients should not have solid food for at least 2 hours before solution is given. Ideally, the patient should fast 3-4 hours prior to GaviLyte-G administration.

    Lukewarm water facilitates dissolution.

    The solution is more palatable if chilled before drinking. However, chilled solution is not recommended for infants.

    GaviLyte-G should be used within 48 hours of reconstituting. Discard any solution that is not used within that time.




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Important Safety Information





  • GaviLyte™-H
    generic of HalfLytely®*
    (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet)

    Should not be used in patients with: gastrointestinal obstruction, bowel perforation, toxic colitis or toxic megacolon, gastric retention, ileus, or in patients with a known sensitivity to any ingredients.

    Use with caution in patients with: risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment or suspected GI obstruction/perforation. Observe patients at risk for aspiration. Ischemic colitis has been reported.

    Adverse Reaction rates observed in clinical studies cannot be directly compared to rates in other studies or reflect rates observed in practice. Most common adverse reactions (>3%) are overall discomfort, abdominal fullness, abdominal cramping, nausea, and vomiting.
    Post approval of the following adverse reactions have been identified:

    Allergic Reactions:
    Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions were reported.

    Gastrointestinal:
    There are isolated reports of serious events following the administration of PEG-based products in patients over 60 years old including upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after vomiting and aspirating the PEG-based solution. During administration of 4 liters of PEG-3350 colon cleanse the following serious adverse reactions were seen: two deaths in end-stage renal failure patients who developed diarrhea, vomiting and dysnatremia. Ischemic colitis has been reported, however, a causal relationship between these ischemic colitis cases and the use of GaviLyte-H and bisacodyl delayed-release tablet, USP has not been established.

    Neurologic: There have been reports of generalized tonic-colonic seizures associated with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. Cases of dizziness and syncope have been reported. Some drugs increase risks due to fluid and electrolyte changes, e.g. diuretics, ACE inhibitors, angiotensin receptor blockers, or NSAIDs. Oral medication taken within 1 hour of dosing might not be properly absorbed. Do not take the bisacodyl tablet within 1 hour of taking antacid.


  • GaviLyte™-C
    generic of CoLyte®*
    (PEG-3350, sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride)

    Should not be used in patients known to be hypersensitive to any of the components and in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

    Should be used with caution in patients with ulcerative colitis. Use with caution in patients with impaired gag reflex, unconscious or semiconscious patients, and patients prone to regurgitation or aspiration should be observed, especially if given via NG tube.


    Adverse Reactions:
    Nausea, abdominal fullness and bloating are the most common adverse reactions, occurring in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient. Isolated cases of urticaria, rhinorrhea, dermatitis and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported, which may represent allergic reactions.


    Pregnancy:
    It is not known whether GaviLyte-C with flavor pack can affect reproductive capacity or harm the fetus when administered to a pregnant patient. Use only if clearly needed.

    Pediatric Use: Safety and effectiveness in pediatric patients have not been established.


    Geriatric Use:
    Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG.

  • GaviLyte™-N
    generic of NuLytely®*
    (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride)

    Should not be used in patients known to be hypersensitive to any of the components and in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon. Should be used with caution in patients with severe ulcerative colitis. Use in children under 2 should be carefully monitored for possible hypoglycemia (solution has no caloric substrate).


    Use with caution in patients with impaired gag reflex, unconscious or semiconscious patients, and patients prone to regurgitation or aspiration should be observed, especially if given via NG tube. If GI obstruction or perforation is suspected, these conditions should be ruled out before administration.


    Pregnancy:
    It is not known whether GaviLyte-N can affect reproductive capacity or harm the fetus when administered to a pregnant patient. Use only if clearly needed.


    Pediatric Use:
    Safety and effectiveness in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of GaviLyte-N in adults with additional safety and efficacy data from published studies of similar formulations.


    Adverse Reactions:
    Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of GaviLyte-N. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reaction following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrate on chest X-ray after vomiting and aspirating PEG.

  • GaviLyte™-G
    generic of GoLytely®*
    (PEG-3350, sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride)

    Should not be used in patients known to be hypersensitive to any of the components and in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon or ileus.

    Use with caution in patients with impaired gag reflex, unconscious or semiconscious patients, and patients prone to regurgitation or aspiration should be observed, especially if given via NG tube. If GI obstruction or perforation is suspected, these conditions should be ruled out before administration.


    Pregnancy:
    It is not known whether GaviLyte-G with flavor pack can affect reproductive capacity or harm the fetus when administered to a pregnant patient. Use only if clearly needed.


    Pediatric Use:
    Safety and effectiveness in pediatric patients have not been established.


    Adverse Reactions:
    Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of GaviLyte-G. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.

    Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG.


A Complete Family of PEG-3350

Bowel Prep Products from GAVIS.

At GAVIS, our complete line of value-branded generic PEG-3350 products is a reflection of our commitment to delivering what prescribers, patients, and pharmacists want, and deserve – a choice.




GaviLyte Family of Products


FAQs


Q: What is the most important information I should know about GaviLyte-H and Bisacodyl Tablet Bowel Prep kit?

A: GaviLyte-H and Bisacodyl Tablet Bowel Prep kit 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:

  • Seizures. This can happen even if you have never had a seizure.
  • Kidney problems
  • Abnormal heartbeats that can cause death


Your chance of having fluid loss and changes in body salts with GaviLyte-H and Bisacodyl Tablet Bowel Prep kit is higher if you:
  • Have heart problems
  • Have kidney problems
  • Take water oils or non-steroidal anti-inflammatory drugs (NSAIDS)


Tell your healthcare provider right away if you have any of the following symptoms of loss of too much body fluid
(dehydration) while taking GaviLyte-H and Bisacodyl Tablet Bowel Prep kit:
  • Dizziness
  • Urinating less frequently than normal
  • Headache

Q: What should I tell my healthcare provider before taking GaviLyte-H and Bisacodyl Tablet Bowel Prep kit?

A: Before you take GaviLyte-H and Bisacodyl Tablet Bowel Prep kit, tell your health 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 alcohol
  • Have a low blood salt (sodium) level
  • Have kidney problems
  • Have any other medical conditions
  • Are pregnant. It is not known if GaviLyte-H and Bisacodyl Tablet Bowel Prep kit 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 GaviLyte-H and Bisacodyl Tablet Bowel Prep kit passes into your breast milk. You and your healthcare provider should decide if you will take GaviLyte-H and Bisacodyl Tablet Bowel Prep kit while breastfeeding.


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


GaviLyte-H and Bisacodyl Tablet Bowel Prep kit may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of GaviLyte-H and Bisacodyl Tablet Prep kit.


Be sure to tell your healthcare provider if you take:

  • Medicines for blood pressure or heart problems
  • Medicines for kidney problems
  • Medicines for depression
  • Water pills (diuretics)
  • Non-steroidal anti-inflammatory medicines (NSAID) pain medicines
  • Laxatives
  • Antacids


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

Q: What is GaviLyte-H and Bisacodyl Tablet Bowel Prep kit?

A: GaviLyte-H and Bisacodyl Tablet Bowel Prep kit is a prescription medicine used by adults to clean the colon before colonoscopy. GaviLyte-H and Bisacodyl Tablet Bowel Prep kit 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 GaviLyte-H and Bisacodyl Tablet Bowel Prep kit is safe and effective in children.

Q: Who should not take GaviLyte-H and Bisacodyl Tablet Bowel Prep kit?

A: Do not take GaviLyte-H and Bisacodyl Tablet Bowel Prep kit if your healthcare provide 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 GaviLyte-H and Bisacodyl Tablet Bowel Prep kit. See here for a complete list of ingredients in GaviLyte-H and Bisacodyl Tablet Bowel Prep kit.

Q: How should I take GaviLyte-H and Bisacodyl Tablet Bowel Prep kit?

A: See the Patient Directions on the outer product carton for dosing instructions, or view them online. You must read, understand and follow these instructions to take GaviLyte-H and Bisacodyl Tablet Bowel Prep kit the right way.


  • Take GaviLyte-H and Bisacodyl Tablet Bowel Prep kit exactly as your healthcare provider tells you to take it.
  • Do not take antacids within 1 hour of taking the Bisacodyl Tablet Bowel Prep kit.
  • Do not chew or crush the Bisacodyl tablet. Take the tablet with water.
  • Do not eat solid foods while taking and after taking GaviLyte-H and Bisacodyl Tablet Bowel Prep kit until after your colonoscopy.
  • Stop drinking GaviLyte-H solution temporarily or allow for longer time between each dose if you have stomach discomfort, pain or bloating until your symptoms improve.
  • Stop taking GaviLyte-H and Bisacodyl Tablet Bowel Prep kit and call your healthcare provider right away if you develop hives or a rash. These may be signs of an allergic reaction.

Q: What are the possible side effects of GaviLyte-H and Bisacodyl Tablet Bowel Prep kit?

A: GaviLyte-H and Bisacodyl Tablet Bowel Prep kit can cause serious side effects, including:


  • Changes in certain blood tests. Your healthcare provider may do blood tests after you take GaviLyte-H and Bisacodyl Bowel Prep kit to check your blood for changes. Tell your healthcare provider if you have any symptoms of fluid loss, including:

    o Vomiting
    o Nausea
    o Bloating
    o Dizziness
    o Stomach or abdominal cramping
    o Headache
    o Urinating less frequently than normal
    o Trouble drinking clear liquid

• Heart problems. GaviLyte-H and Bisacodyl Tablet Bowel Prep kit may cause irregular heartbeats.
• Seizures
• Decreased blood flow to the intestine (ischemic colitis).


There have been reports of ischemic colitis in people who have taken GaviLyte-H and Bisacodyl Tablet Bowel Prep kit at higher doses. Tell your healthcare provider right away if you have severe stomach (abdominal) pain or rectal bleeding. These may be symptoms of ischemic colitis.


The most common side effects of GaviLyte-H and Bisacodyl Tablet Bowel Prep kit 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 GaviLyte-H and Bisacodyl Tablet Bowel Prep kit. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Q: How should I store GaviLyte-H and Bisacodyl Tablet Bowel Prep kit?

A:
• Store GaviLyte-H and Bisacodyl Tablet Bowel Prep kit at room temperature, between 59°F to 86°F (15°C to 30°C)
• GaviLyte-H solution that has been mixed with water may be refrigerated. Mixed solution should be taken within 48 hours.

• Keep GaviLyte-H and Bisacodyl Tablet Bowel Prep kit and all medicines out of the reach of children.

Q: Is there any general information about the safe and effective use of GaviLyte-H and Bisacodyl Tablet?

A: Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GaviLyte-H and Bisacodyl Tablet Prep kit for a condition for which it was not prescribed. Do not give GaviLyte-H and Bisacodyl Tablet Bowel Prep kit to other people, even if they are going to have the same procedure you are. It may harm them.

Q: What are the ingredients in GaviLyte-H and Bisacodyl Tablet Bowel Prep kit?

A:
Bisacodyl delayed-release tablet:
• Active: bisacodyl
• Inactive: lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, D&C red #27/phloxine aluminum lake, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, FD&C blue #2/indigo carmine aluminum lake and FD&C yellow #6/sunset yellow FCF aluminum lake


GaviLyte-H solution:
• Active: polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride
• Inactive: cherry, lemon-lime and orange artificial flavor packs

Helpful Hints

Open book icon

Educate Yourself

The more you know, the more likely you are to use your prep kit effectively. Make sure you thoroughly understand:

• Every step of the process

• Any specific instructions your healthcare provider has given you for before or after your prep

• Know what you can (and can't) eat and drink, and when. Some patients may find it helpful to label what they’re allowed to consume in their fridge.


Restroom icon

Be Prepared

It's best to be ready before you begin drinking the solution. Since you'll be spending most of the time in the bathroom, it's important to remain comfortable.

• Keep a book, magazine, tablet, laptop or other electronic device nearby. This will help keep you preoccupied both in and out of the bathroom.

• Wear clothing that is comfortable and easy to take off and put back on.

• Moistened wipes will help you avoid the irritation that comes from using toilet paper repeatedly. Keep them in your bathroom.

PEG-3350 solution container icon

Stick it Out

If you don't drink the entirety of the solution, there's a chance your colon won't be properly cleansed.

• As a result, the colonoscopy may take longer, and there's a chance your doctor may ask you to go through the bowel prep process all over again.

• Now, we know this isn't the most pleasant process, but it's definitely better than having to do it twice. Finishing the entire solution is the most important part to successful bowel preparation.




Beverage icon

DO Eat and Drink

• Water

• Fruit juices without pulp including orange, apple, white grape, or white cranberry

• Clear broth or bouillon

• Plain gelatin dessert that is not red or purple

• Coffee and tea

• Lemonade or limeade

• Ginger ale

No symbol icon

DO NOT Eat or Drink

• Anything colored red or purple

• Any solid foods 3 to 4 hours before drinking the solution

• Any solid foods for 2 hours after taking the solution

• Any opaque liquids

• Any alcoholic beverages

Relaxing figure icon

Relax

Stress can lead to discomfort, but more importantly, it can lead to mistakes. That's why it's crucial to be relaxed throughout the bowel prep process.

• Watch your favorite TV show or movie to help keep you distracted.

• Put on soothing music to help you remain calm.

• Light pleasant smelling candles.

• When you're not in the bathroom, prop yourself up with pillows in your bed.





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