RENAL IMPAIRMENT SUBSECTION.

8.6 Renal Impairment. Use GoLYTELY with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions 7.1)] These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of GoLYTELY and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions 5.4)].

SPL MEDGUIDE SECTION.

Medication GuideGoLYTELY(R) (Go-lite-ly)(PEG-3350 and Electrolytes)for oral solutionRead this Medication Guide before you start taking GoLYTELY. 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 should know about GoLYTELYGoLYTELY 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 (arrhythmias) that can cause death.seizures. This can happen even if you have never had seizure. kidney problems.Your chance of having fluid loss and changes in body salts with GoLYTELY 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 loss of too much body fluid(dehydration) while taking GoLYTELY: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 GoLYTELY for more information about side effects.What is GoLYTELYGoLYTELY is prescription medicine used by adults to clean the colon before colonoscopy or barium enema X-ray examination. GoLYTELY 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 GoLYTELY is safe and effective in children.Who should not take GoLYTELYDo not take GoLYTELY 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).a very dilated intestine (toxic megacolon).problems with food and fluid emptying from your stomach (gastric retention).a problem with food moving too slowly through your intestines (ileus).an allergy to any of the ingredients in GoLYTELY. See the end of this Medication Guide for complete list of ingredients in GoLYTELY.What should tell my healthcare provider before taking GoLYTELYBefore you take GoLYTELY, 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 history of seizures.are withdrawing from drinking alcohol.have low blood salt (sodium) level.have kidney problems.have any other medical conditions.are pregnant. It is not known if GoLYTELY 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 GoLYTELY passes into your breast milk. You and your healthcare provider should decide if you will take GoLYTELY while breastfeeding.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GoLYTELY may affect how other medicines work. Do not take medicines by mouth within hour of starting GoLYTELY or after you start taking GoLYTELY. 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 GoLYTELY with starch-based thickeners.Ask your healthcare provider or pharmacist for 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 list of them to show your healthcare provider and pharmacist when you get new medicine. How should take GoLYTELYYou must read, understand, and follow these instructions to take GoLYTELY the right way.Take GoLYTELY exactly as your healthcare provider tells you to take itSee the Instructions for Use on the bottle label for instructions on how to mix, take or give GoLYTELY.Do not take undissolved GoLYTELY powder that has not been mixed with water (diluted). It may increase your risk of nausea, vomiting and fluid loss (dehydration).Do not take other laxatives while taking GoLYTELY.Drink reconstituted solution at rate of ounces (240 ml) every 10 minutes. Rapid drinking of each portion is better than drinking small amounts.Do not eat or drink anything colored red or purple.Do not eat solid foods at least hours before taking GoLYTELY. You may eat light breakfast hours before taking GoLYTELY. For best results, do not consume solid food for to hours before drinking GoLYTELY. Drink only water and clear liquids: the day before your colonoscopy while taking GoLYTELY after taking GoLYTELY until hours before your colonoscopy. Drink clear liquids before, during, and after you take GoLYTELY to avoid fluid loss (dehydrated). Examples of clear liquids are: water clear broth clear fruit juices without pulp including apple, white grape, clear soda or white cranberry strained limeade or lemonade gelatin (without added fruit or topping) coffee or tea (Do not use any dairy or non-dairy creamer) popsicles without pieces of fruit or fruit pulp You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, slow or temporarily stop (discontinue) drinking the solution and contact your healthcare provider.The first bowel movement should occur approximately one hour after you start drinking the solution.Continue drinking until the watery stool is clear and free of solid matter.What are the possible side effects of GoLYTELYGoLYTELY can cause serious side effects, including:See Section What is the most important information should know about GoLYTELYchanges in certain blood tests. Your healthcare provider may do blood tests before and after you take GoLYTELY to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: vomiting stomach (abdominal) cramping nausea headache bloating urinate less than usual dizziness trouble drinking clear liquid 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 GoLYTELY include:o nausea stomach (abdominal) cramps anal irritation stomach (abdominal) fullness vomiting esophageal bleeding bloating chest x-ray that shows water in the lungs (infiltrate) after vomiting or inhaling food or liquid (aspirate). 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 GoLYTELY. 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 store GoLYTELYo Store GoLYTELY in sealed container at room temperature, between 59oF to 86F (15oC to 30C). Store mixed (reconstituted) solution of GoLYTELY at 36 to 46F (2C to 8C). Do not freeze. Use mixed (reconstituted) solution of GoLYTELY within 48 hours. After 48 hours, throw away (discard) any mixed (reconstituted) solution of GoLYTELY that is not used. Keep GoLYTELY and all medicines out of the reach of children. General information about the safe and effective use of GoLYTELY.Medicines are sometimes prescribed for purposes other than those listed in Medication Guide. Do not use GoLYTELY for condition for which it was not prescribed. Do not give GoLYTELY 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 GoLYTELY. 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. What are the ingredients in GoLYTELYGoLYTELY comes in 4-liter jug with GoLYTELY powder. Active ingredients: Powder for solution: polyethylene glycol 3350, sodium sulfate (anhydrous), sodium bicarbonate, sodium chloride, and potassium chloride. Manufactured by Braintree Laboratories, Inc. 270 Centre Street Holbrook, MA 02343 Marketed by Braintree, Part of Sebela Pharmaceuticals(R) 60 Columbian Street West Braintree, MA 02185 For more information go to www.braintreelabs.com or call 1-800-874-6756. This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2021 abnormal heartbeats (arrhythmias) that can cause death.. seizures. This can happen even if you have never had seizure. kidney problems.. have heart problems.. have kidney problems.. take water pills or non-steroidal anti-inflammatory drugs (NSAIDS).. vomiting that prevents you from keeping down the solution.. dizziness.. urinating less often than normal.. headache.. blockage in your bowel (obstruction).. an opening in the wall of your stomach or intestine (bowel perforation).. very dilated intestine (toxic megacolon).. problems with food and fluid emptying from your stomach (gastric retention).. problem with food moving too slowly through your intestines (ileus).. an allergy to any of the ingredients in GoLYTELY. See the end of this Medication Guide for complete list of ingredients in GoLYTELY.. have heart problems.. have stomach or bowel problems.. have ulcerative colitis.. have problems with swallowing or gastric reflux.. have history of seizures.. are withdrawing from drinking alcohol.. have low blood salt (sodium) level.. have kidney problems.. have any other medical conditions.. are pregnant. It is not known if GoLYTELY 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 GoLYTELY passes into your breast milk. You and your healthcare provider should decide if you will take GoLYTELY while breastfeeding.. 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 GoLYTELY with starch-based thickeners.. Take GoLYTELY exactly as your healthcare provider tells you to take it. See the Instructions for Use on the bottle label for instructions on how to mix, take or give GoLYTELY.. Do not take undissolved GoLYTELY powder that has not been mixed with water (diluted). It may increase your risk of nausea, vomiting and fluid loss (dehydration).. Do not take other laxatives while taking GoLYTELY.. Drink reconstituted solution at rate of ounces (240 ml) every 10 minutes. Rapid drinking of each portion is better than drinking small amounts.. Do not eat or drink anything colored red or purple.. Do not eat solid foods at least hours before taking GoLYTELY. You may eat light breakfast hours before taking GoLYTELY. For best results, do not consume solid food for to hours before drinking GoLYTELY. Drink only water and clear liquids: the day before your colonoscopy while taking GoLYTELY after taking GoLYTELY until hours before your colonoscopy. Drink clear liquids before, during, and after you take GoLYTELY to avoid fluid loss (dehydrated). Examples of clear liquids are: water clear broth clear fruit juices without pulp including apple, white grape, clear soda or white cranberry strained limeade or lemonade gelatin (without added fruit or topping) coffee or tea (Do not use any dairy or non-dairy creamer) popsicles without pieces of fruit or fruit pulp You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, slow or temporarily stop (discontinue) drinking the solution and contact your healthcare provider.. The first bowel movement should occur approximately one hour after you start drinking the solution.. Continue drinking until the watery stool is clear and free of solid matter.. See Section What is the most important information should know about GoLYTELY. changes in certain blood tests. Your healthcare provider may do blood tests before and after you take GoLYTELY to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: vomiting stomach (abdominal) cramping nausea headache bloating urinate less than usual dizziness trouble drinking clear liquid 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display PanelFILL TO THE TOP OF THE LINE ON BOTTLENDC 52268-100-01TO PHARMACIST AND PATIENT: Mixing information is on base label. Package insert may be removed before dispensing.Dispense the enclosed Medication Guide to each patient.GoLYTELY (R) PEG-3350 and Electrolytes for Oral SolutionWhen reconstituted with water to volume of liters, this solution contains PEG-3350 59 g/L, sodium sulfate 5.69 g/L, sodium bicarbonate 1.69 g/L, sodium chloride 1.47 g/L, and potassium chloride 0.743 g/L.Each disposable jug contains, in powdered form: polyethylene glycol 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g.RX onlyManufactured by Braintree Laboratories, Inc., Braintree, MA 02185Marketed by Braintree, part of Sebela Pharmaceuticals(R). GoLYTELY Label. Base Label.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. Safety and effectiveness of GoLYTELY in pediatric patients have not been established.

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics. GoLYTELY induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics. The pharmacokinetics of PEG3350 following administration of GoLYTELY were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following clinically significant adverse reactions are described elsewhere in the labeling:Renal impairment [see Warnings and Precautions 5.4)] Colonic mucosal ulcerations and ischemic colitis [see Warnings and Precautions 5.5)] Patients with significant gastrointestinal disease [see Warnings and Precautions 5.6)] Aspiration [see Warnings and Precautions 5.7)] The following adverse reactions associated with the use of GoLYTELY were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish causal relationship to drug exposure.Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions 5.2)] Nervous system: tremor, seizure [see Warnings and Precautions 5.3)] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications 4), Warnings and Precautions 5.8)] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients). Other less common adverse reactions include: abdominal cramps, vomiting, butterfly-like infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)].. Renal impairment [see Warnings and Precautions 5.4)] Colonic mucosal ulcerations and ischemic colitis [see Warnings and Precautions 5.5)] Patients with significant gastrointestinal disease [see Warnings and Precautions 5.6)] Aspiration [see Warnings and Precautions 5.7)] Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions 5.2)] . Nervous system: tremor, seizure [see Warnings and Precautions 5.3)] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications 4), Warnings and Precautions 5.8)] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients). Other less common adverse reactions include: abdominal cramps, vomiting, butterfly-like infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)].. Most common adverse reactions are: nausea, abdominal fullness, bloating, abdominal cramps, vomiting and anal irritation. 6) To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc. at 1-800-874-6756 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces watery stool.. 12.2 Pharmacodynamics. GoLYTELY induces as diarrhea which rapidly cleanses the bowel, usually within four hours.. 12.3 Pharmacokinetics. The pharmacokinetics of PEG3350 following administration of GoLYTELY were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. GoLYTELY is contraindicated in the following conditions:Gastrointestinal (GI) obstruction [see Warnings and Precautions 5.6)] Bowel perforation [see Warnings and Precautions 5.6)] Toxic colitis or toxic megacolonGastric retentionIleusHypersensitivity to any component of GoLYTELY [see Warnings and Precautions 5.8)] Gastrointestinal (GI) obstruction [see Warnings and Precautions 5.6)] Bowel perforation [see Warnings and Precautions 5.6)] Toxic colitis or toxic megacolon. Gastric retention. Ileus. Hypersensitivity to any component of GoLYTELY [see Warnings and Precautions 5.8)] Gastrointestinal (GI) obstruction 4, 5.6) Bowel perforation 4, 5.6) Toxic colitis or toxic megacolon 4) Gastric retention 4) Ileus 4) Hypersensitivity to components of GoLYTELY 4, 5.8) Gastrointestinal (GI) obstruction 4, 5.6) Bowel perforation 4, 5.6) Toxic colitis or toxic megacolon 4) Gastric retention 4) Ileus 4) Hypersensitivity to components of GoLYTELY 4, 5.8).

DESCRIPTION SECTION.

11 DESCRIPTION. GoLYTELY is combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in 4-liter disposable jug containing 236 polyethylene glycol 3350, 22.74 sodium sulfate (anhydrous), 6.74 sodium bicarbonate, 5.86 sodium chloride, and 2.97 potassium chloride as white powder.Polyethylene Glycol 3350, USPSodium Sulfate, USPThe chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is: Sodium Bicarbonate, USPThe chemical name is NaHCO 3. The average Molecular Weight is 84.01. The structural formula is: Sodium Chloride, USPThe chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:Na Cl Potassium Chloride, USPThe chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:K-Cl. Polyethylene Glycol 3350 Structural Formula. Sodium Sulfate Structural Formula. Sodium Bicarbonate Structural Formula.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. Preparation and Administration 2.1): Correct fluid and electrolyte abnormalities before treatment with GoLYTELY.Reconstitute GoLYTELY with water prior to ingestion.Do not take oral medications within hour before the start or during administration of GoLYTELY. 2.1) Do not take other laxatives while taking GoLYTELY.Consume only clear liquids; avoid red and purple liquids.Consume water or other clear liquids up until hours before the time of the colonoscopy.Do not consume solid food within hours before starting GoLYTELY.Adult Dosing Regimen 2.2): On day prior to colonoscopy, instruct patients to consume light breakfast at least hours before starting GoLYTELY.Begin the recommended dosage regimen for GoLYTELY early in the evening on the day before colonoscopyDrink reconstituted solution at rate of ounces every 10 minutes, until liters are consumed, or rectal effluent is clear.For complete information on dosing, preparation and administration, see the full prescribing information. 2.1, 2.2) Correct fluid and electrolyte abnormalities before treatment with GoLYTELY.. Reconstitute GoLYTELY with water prior to ingestion.. Do not take oral medications within hour before the start or during administration of GoLYTELY. 2.1) Do not take other laxatives while taking GoLYTELY.. Consume only clear liquids; avoid red and purple liquids.. Consume water or other clear liquids up until hours before the time of the colonoscopy.. Do not consume solid food within hours before starting GoLYTELY.. On day prior to colonoscopy, instruct patients to consume light breakfast at least hours before starting GoLYTELY.. Begin the recommended dosage regimen for GoLYTELY early in the evening on the day before colonoscopy. Drink reconstituted solution at rate of ounces every 10 minutes, until liters are consumed, or rectal effluent is clear.. For complete information on dosing, preparation and administration, see the full prescribing information. 2.1, 2.2) 2.1 Important Preparation and Administration Instructions. Correct fluid and electrolyte abnormalities before treatment with GoLYTELY [see Warnings and Precautions 5.1)] Reconstitute GoLYTELY with water prior to ingestion, do not take undissolved GoLYTELY [see Dosage and Administration 2.2)] Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions 5.7)] Do not take oral medications within hour before the start of or during administration of GoLYTELY [see Drug Interactions 7.2)] Do not take other laxatives while taking GoLYTELY [see Drug Interactions 7.3)] Consume only clear liquids, avoid red and purple liquids.Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until hours before the time of the colonoscopy.The solution is more palatable if chilled prior to administration.Do not consume solid food within hours before starting GoLYTELY. For the best results, do not consume solid food for to hours before drinking the solution.If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue GoLYTELY until the symptoms abate.. Correct fluid and electrolyte abnormalities before treatment with GoLYTELY [see Warnings and Precautions 5.1)] . Reconstitute GoLYTELY with water prior to ingestion, do not take undissolved GoLYTELY [see Dosage and Administration 2.2)] Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions 5.7)] . Do not take oral medications within hour before the start of or during administration of GoLYTELY [see Drug Interactions 7.2)] . Do not take other laxatives while taking GoLYTELY [see Drug Interactions 7.3)] . Consume only clear liquids, avoid red and purple liquids.. Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until hours before the time of the colonoscopy.. The solution is more palatable if chilled prior to administration.. Do not consume solid food within hours before starting GoLYTELY. For the best results, do not consume solid food for to hours before drinking the solution.. If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue GoLYTELY until the symptoms abate.. 2.2 Dosage Regimen. Instruct adult patients that on the day before the colonoscopy procedure, they may consume light breakfast at least hours before starting GoLYTELY. Begin the recommended dosage regiment for GoLYTELY early in the evening on the day before colonoscopy.Instruct patients to take GoLYTELY in conjunction with clear liquids as follows:4 Liter JugFill the supplied container containing the GoLYTELY powder with lukewarm drinking water to the 4-liter fill lineDo not add any other ingredients, flavors, etc.After capping the container, shake vigorously several times to ensure that the ingredients are dissolved.Drink at rate of ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. loose watery bowel movement should result in approximately one hour.After reconstitution, keep solution refrigerated to 8C (36 to 46F). Do not freeze. Use within 48 hours, discard unused portion.Administration via Nasogastric TubeFor patients with nasogastric tube, administer the reconstituted GoLYTELY solution at rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).. Fill the supplied container containing the GoLYTELY powder with lukewarm drinking water to the 4-liter fill line. Do not add any other ingredients, flavors, etc.. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved.. Drink at rate of ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. loose watery bowel movement should result in approximately one hour.. After reconstitution, keep solution refrigerated to 8C (36 to 46F). Do not freeze. Use within 48 hours, discard unused portion.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. For Oral Solution: 236 polyethylene glycol 3350, 22.74 sodium sulfate (anhydrous), 6.74 sodium bicarbonate, 5.86 sodium chloride and 2.97 potassium chloride as white powder. When reconstituted with water to volume of liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.. For Oral Solution: 236 polyethylene glycol 3350, 22.74 sodium sulfate (anhydrous), 6.74 sodium bicarbonate, 5.86 sodium chloride and 2.97 potassium chloride per liters.

DRUG INTERACTIONS SECTION.

7 DRUG INTERACTIONS. Some drugs increase risks due to fluid and electrolyte changes 7.1) 7.1 Drugs that May Increase Risks Due to Fluid and Electrolyte Abnormalities. Use caution when prescribing GoLYTELY for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities see Warnings and Precautions 5.1, 5.2, 5.3, 5.4) ]. Consider additional patient evaluations as appropriate. 7.2 Potential for Reduced Drug Absorption. GoLYTELY can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of GoLYTELY [see Dosage and Administration 2.1)] . 7.3 Stimulant Laxatives. Concurrent use of stimulant laxatives and GoLYTELY may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking GoLYTELY [see Warnings and Precautions 5.5)].

GERIATRIC USE SECTION.

8.5 Geriatric Use. Clinical studies of GoLYTELY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING. GoLYTELY (polyethylene glycol 3350 and electrolytes for oral solution) is supplied in 4-liter disposable jug containing 236 polyethylene glycol 3350, 22.74 sodium sulfate (anhydrous), 6.74 sodium bicarbonate, 5.86 sodium chloride and 2.97 potassium chloride as white powder.When reconstituted with water to volume of liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.GoLYTELY Liter Disposable Jug NDC 52268-100-01. When reconstituted with water to volume of liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.. StorageStore in sealed container at 15 to 30C (59 to 86F).Store reconstituted solution of GoLYTELY at to 8C (36 to 46F). Do not freeze [see Dosage and Administration 2.1)].

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.. GoLYTELY is combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults 1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).Instruct Patients:To reconstitute GoLYTELY with water prior to ingestion.Not to take other laxatives while they are taking GoLYTELY.Not to take oral medications within hour before the start or during the administration of GoLYTELY.To take only clear liquids but avoid red and purple liquids.To consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until hours before the time of the colonoscopy.To follow the directions in the Instructions for Use on how to prepare and administer the product. If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider.To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures. [see Warnings and Precautions 5.1, 5.2, 5.3, 5.4)] To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of hypersensitivity reaction [see Warnings and Precautions 5.8)] Manufactured by Braintree Laboratories, Inc. 270 Centre Street Holbrook, MA 02343Marketed by Braintree, Part of Sebela Pharmaceuticals(R). 60 Columbian Street West Braintree, MA 02185. To reconstitute GoLYTELY with water prior to ingestion.. Not to take other laxatives while they are taking GoLYTELY.. Not to take oral medications within hour before the start or during the administration of GoLYTELY.. To take only clear liquids but avoid red and purple liquids.. To consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until hours before the time of the colonoscopy.. To follow the directions in the Instructions for Use on how to prepare and administer the product. If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider.. To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures. [see Warnings and Precautions 5.1, 5.2, 5.3, 5.4)] . To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of hypersensitivity reaction [see Warnings and Precautions 5.8)].

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces watery stool.

NURSING MOTHERS SECTION.

8.3 Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GoLYTELY is administered to nursing woman.

PREGNANCY SECTION.

8.1 Pregnancy. Animal reproduction studies have not been conducted with GoLYTELY. It is also not known whether GoLYTELY can cause fetal harm when administered to pregnant woman or can affect reproductive capacity. GoLYTELY should be given to pregnant woman only if clearly needed.

RECENT MAJOR CHANGES SECTION.

Warnings and Precautions, Aspiration: 5.7) 05/2021.

SPL UNCLASSIFIED SECTION.

2.1 Important Preparation and Administration Instructions. Correct fluid and electrolyte abnormalities before treatment with GoLYTELY [see Warnings and Precautions 5.1)] Reconstitute GoLYTELY with water prior to ingestion, do not take undissolved GoLYTELY [see Dosage and Administration 2.2)] Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions 5.7)] Do not take oral medications within hour before the start of or during administration of GoLYTELY [see Drug Interactions 7.2)] Do not take other laxatives while taking GoLYTELY [see Drug Interactions 7.3)] Consume only clear liquids, avoid red and purple liquids.Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until hours before the time of the colonoscopy.The solution is more palatable if chilled prior to administration.Do not consume solid food within hours before starting GoLYTELY. For the best results, do not consume solid food for to hours before drinking the solution.If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue GoLYTELY until the symptoms abate.. Correct fluid and electrolyte abnormalities before treatment with GoLYTELY [see Warnings and Precautions 5.1)] . Reconstitute GoLYTELY with water prior to ingestion, do not take undissolved GoLYTELY [see Dosage and Administration 2.2)] Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions 5.7)] . Do not take oral medications within hour before the start of or during administration of GoLYTELY [see Drug Interactions 7.2)] . Do not take other laxatives while taking GoLYTELY [see Drug Interactions 7.3)] . Consume only clear liquids, avoid red and purple liquids.. Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until hours before the time of the colonoscopy.. The solution is more palatable if chilled prior to administration.. Do not consume solid food within hours before starting GoLYTELY. For the best results, do not consume solid food for to hours before drinking the solution.. If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue GoLYTELY until the symptoms abate.

STORAGE AND HANDLING SECTION.

StorageStore in sealed container at 15 to 30C (59 to 86F).Store reconstituted solution of GoLYTELY at to 8C (36 to 46F). Do not freeze [see Dosage and Administration 2.1)].

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Animal reproduction studies have not been conducted with GoLYTELY. It is also not known whether GoLYTELY can cause fetal harm when administered to pregnant woman or can affect reproductive capacity. GoLYTELY should be given to pregnant woman only if clearly needed.. 8.3 Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GoLYTELY is administered to nursing woman.. 8.4 Pediatric Use. Safety and effectiveness of GoLYTELY in pediatric patients have not been established.. 8.5 Geriatric Use. Clinical studies of GoLYTELY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.. 8.6 Renal Impairment. Use GoLYTELY with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions 7.1)] These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of GoLYTELY and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions 5.4)].

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. 5.1, 5.2, 7.1) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. 5.2) Seizures: Use caution in patients with history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold. 5.3, 7.1) Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing. 5.4, 7.1, 8.6) Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. 5.5, 7.3) Patients at risk for aspiration: Observe during administration. 5.7) Hypersensitivity reactions including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. 5.8) Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. 5.1, 5.2, 7.1) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. 5.2) Seizures: Use caution in patients with history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold. 5.3, 7.1) Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing. 5.4, 7.1, 8.6) Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. 5.5, 7.3) Patients at risk for aspiration: Observe during administration. 5.7) Hypersensitivity reactions including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. 5.8) 5.1 Serious Fluid and Serum Chemistry Abnormalities. Advise patients to hydrate adequately before, during, and after the use of GoLYTELY. Use caution in patients with congestive heart failure when replacing fluids. If patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking GoLYTELY, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with GoLYTELY.In addition, use caution when prescribing GoLYTELY for patients who have conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment see Drug Interactions 7.1) ]. 5.2 Cardiac Arrythmias. There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing GoLYTELY for patients at increased risk of arrhythmias (e.g., patients with history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.. 5.3 Seizures. There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.Use caution when prescribing GoLYTELY for patients with history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions 7.1)] . 5.4 Renal Impairment. Use caution when prescribing GoLYTELY for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions 7.1)] Advise these patients of the importance of adequate hydration and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use is Specific Populations 8.6)] . 5.5 Colonic Mucosal Ulcerations and Ischemic Colitis. Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and GoLYTELY may increase this risk [see Drug Interactions 7.3)] Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD). 5.6 Use in Patients with Significant Gastrointestinal Disease. If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering GoLYTELY [see Contraindications 4)] Use with caution in patients with severe active ulcerative colitis. 5.7 Aspiration. Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Observe these patients during administration of GoLYTELY, especially if it is administered via nasogastric tube.Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Observe these patients during administration of GoLYTELY, especially if it is administered via nasogastric tube.Do not combine GoLYTELY with starch-based thickeners [see Dosage and Administration 2.1)] Polyethylene glycol (PEG), component of GoLYTELY, when mixed with starch- thickened liquids reduces the viscosity of the starch-thickened liquid. When PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of choking and potential aspiration were reported. 5.8 Hypersensitivity Reactions. GoLYTELY contains PEG and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see Adverse Reactions 6)] Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.