PEG-3350, ELECTROLYTES, AND ASCORBATE

Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative consisting of 4 pouches (2 of Pouch A and 2 of Pouch B) containing white to yellow powder for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride, plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring containing citral, lime oil, maltodextrin, acacia gum, vitamin E, and other natural flavoring agents. Pouch A contains 111.9 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. Pouch B contains 10.6 g of powder for oral solution. When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an oral solution having a lemon taste. The entire, reconstituted, 2-liter Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution colon preparation contains 200 grams of polyethylene glycol-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 131 mg per treatment.

Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. ( 1 )

Preparation and Administration: • Two doses of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution are required for a complete preparation for colonoscopy, using a “Two-Day” preferred method or “One-Day” alternative method dosing regimen. ( 2.1 ) • Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution must be reconstituted in water prior to ingestion. ( 2.1 ) • Additional clear liquids must be consumed after each dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution in both dosing regimens. ( 2.1 , 5.1 ) • Do not take other laxatives while taking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. ( 2.1 , 5.5 ) • Do not take oral medications within 1 hour of starting each dose. ( 2.1 ) Dosing Regimen: • Two-Day (Split-Dose) (Preferred Method): Dose 1 the evening before the colonoscopy, and Dose 2 the morning of the colonoscopy (approximately 12 hours after the start of Dose 1, and at least 3 ½ hours prior to the colonoscopy). ( 2.2 ) • One-Day (Evening Only) (Alternative Method) : Dose 1 at least 3 ½ hours prior to bedtime the evening before the colonoscopy and Dose 2 approximately 1 ½ hours after starting Dose 1 the evening before the colonoscopy. ( 2.3 ) • For complete information on dosing, preparation and administration see full prescribing information ( 2.1 , 2.2 , 2.3 ) 2.1 Important Preparation and Administration Instructions • Correct fluid and electrolyte abnormalities before treatment with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Warnings and Precautions ( 5.1 )]. • Two doses of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution are required for a complete preparation for colonoscopy. The time interval between the two doses depends on the regimen prescribed and the planned timing of the colonoscopy procedure. [see Dosage and Administration ( 2.2 , 2.3 ) ] . • The “Split-Dose” is the preferred method and consists of two separate doses: the first dose is taken the evening before the colonoscopy, and the second dose is taken the next day, the morning of the day of the colonoscopy [see Dosage and Administration ( 2.2 )]. • The “Evening Only” is the alternative method and consists of two separate doses: both doses are taken in the evening before the day of the colonoscopy, with a minimum of 1.5 hours between the start of the first dose and the start of the second dose [see Dosage and Administration ( 2.3 )]. • Both Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution dosing regimens require administration of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution using the mixing container provided to reconstitute the contents of Pouch A and B with water to the Fill Line. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions ( 5.7 )]. • Additional clear liquids (including water) must be consumed in both dosing regimens [see Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions ( 5.1 )] . • Consume only clear liquids (no solid food) from the start of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution treatment until after the colonoscopy. • Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material. • Do not take other laxatives while taking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Drug Interactions ( 7.3 )] . • Do not take oral medications within 1 hour before or after starting each dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Drug Interactions ( 7.2 )]. • Ensure completion of Dose 2, including all additional liquids, at least 2 hours before the colonoscopy. • Storage : After reconstitution, store Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution in an upright position and keep refrigerated. Use within 24 hours after it is mixed in water. 2.2 Two-Day Split-Dosing Regimen (Preferred Method) The Two-Day Split-Dosing regimen is the preferred dosing method. Instruct adult patients that on the day before the clinical procedure, they can consume breakfast, followed by a light lunch (no solid foods), and clear soup and/or plain yogurt for dinner, which must be completed at least 1 hour prior to the start of the first Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution dose. Instruct adult patients to take two separate doses in conjunction with fluids as follows: Dose 1 – In the evening before the colonoscopy, approximately 10 to 12 hours before Dose 2: 1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 2. Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 3. Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved. 4. Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all the solution. 5. Refill the mixing container halfway to the Fill Line (at least 16 ounces) with a clear liquid and drink all this liquid before going to bed. Dose 2 – Take next morning, on the day of the colonoscopy, approximately 12 hours after the start of Dose 1 and at least 3 ½ hours prior to colonoscopy: 1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 2. Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 3. Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved. 4. Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all of the solution. 5. Refill the mixing container halfway to the Fill Line (at least 16 ounces) with a clear liquid and drink all this liquid at least 2 hours before the colonoscopy. 6. Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy. Stop drinking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve. 2.3 One-Day Evening Only Dosing Regimen (Alternative Method) The One-Day Evening Only regimen is the alternative dosing method for patients for whom the Split-Dosing regimen is inappropriate. Instruct adult patients that on the day before the clinical procedure, they can consume breakfast, followed by a light lunch (no solid foods), and clear soup and/or plain yogurt for dinner, which must be completed at least 1 hour prior to the start of the first Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution dose. Instruct adult patients to take two separate doses in conjunction with fluids as follows: Dose 1 – At least 3 ½ hours before bedtime the evening before the colonoscopy : 1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 2. Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 3. Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved. 4. Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all the solution. Dose 2 – At least 1 ½ hours after starting Dose 1 on the evening before the colonoscopy : 1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 2. Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 3. Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved. 4. Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all of the solution. 5. Refill the mixing container to the Fill Line (32 fluid ounces) with a clear liquid and drink all this liquid before going to bed. 6. Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy. Stop drinking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.

Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is contraindicated in the following conditions: • Gastrointestinal (GI) obstruction [see Warnings and Precautions ( 5.6 )] • Bowel perforation [see Warnings and Precautions ( 5.6 )] • Gastric retention • Ileus • Toxic colitis or toxic megacolon • Hypersensitivity to any ingredient in Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Warnings and Precautions ( 5.10 ) and Description ( 11 )] • Gastrointestinal (GI) obstruction ( 4 , 5.6 ) • Bowel perforation ( 4 , 5.6 ) • Gastric retention ( 4 ) • Ileus ( 4 ) • Toxic colitis or toxic megacolon ( 4 ) • Hypersensitivity to any ingredient in Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution ( 4 , 5.10 )

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: • Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions (5.1) ] • Cardiac Arrhythmias [see Warnings and Precautions (5.2) ] • Seizures [see Warnings and Precautions (5.3)] • Patients with Renal Impairment [see Warnings and Precautions (5.4)] • Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative 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)] • Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency [see Warnings and Precautions (5.8)] • Risks in Patients with Phenylketonuria [see Warnings and Precautions (5.9)] • Hypersensitivity Reactions [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥ 5%) are: • Two-Day (Split-Dose): malaise, nausea, abdominal pain, vomiting, and upper abdominal pain. ( 6.1 ) • One-Day (Evening-Only): abdominal distension, anal discomfort, thirst, nausea, abdominal pain, sleep disorder, rigors, hunger, malaise, vomiting, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution as a Two-Day Split-Dosing and One-Day Evening Only Dosing Regimen was evaluated in two randomized, active-controlled, multicenter, investigator-blinded clinical trials in adult patients scheduled to have an elective colonoscopy [see Clinical Studies (14) ] . The safety analysis for Study 1 included 359 adult patients ranging in age from 18 to 88 years (mean age 59), with 52% female and 48% male patients. The safety analysis for Study 2 included 340 adult patients ranging in age from 21 to 76 years (mean age 53), with 53% male and 47% female patients. Tables 1 and 2 display adverse reactions reported in at least 2% and 5% of patients in either treatment group in Study 1 and Study 2, respectively. Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials. Table 1: Common Adverse Reactions Reported in at least 2% of patients in either treatment group in Patients Undergoing Colonoscopy in Study 1 Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution Two-Day Split Dosing Regimen (N=180) 4 Liter PEG + Electrolytes Solution (N=179) Malaise 19% 18% Nausea 14% 20% Abdominal pain 13% 15% Vomiting 8% 13% Upper abdominal pain 6% 6% Dyspepsia 3% 1% Table 2: Common Adverse Reactions Reported in at least 5% of patients in either treatment group Patients were specifically asked about the occurrence of the following symptoms: shivering, anal irritations, abdominal bloating or fullness, sleep loss, nausea, vomiting, weakness, hunger sensation, abdominal cramps or pain, thirst sensation, and dizziness. in Patients Undergoing Colonoscopy in Study 2 Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution One-Day Evening Only Dosing Regimen (N=169) 90 mL Oral Sodium Phosphate Solution (N=171) Abdominal distension 60% 41% Anal discomfort 51% 52% Thirst 47% 65% Nausea 47% 47% Abdominal pain 39% 32% Sleep disorder 35% 29% Rigors 34% 30% Hunger 30% 71% Malaise 27% 53% Vomiting 7% 8% Dizziness 7% 18% Headache 2% 5% Hypokalemia 0% 6% Hyperphosphatemia 0% 6% 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution or other PEG-based products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema, asystole, acute pulmonary edema and syncope, and dehydration. Gastrointestinal: upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]. Hypersensitivity reactions: anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness, rhinorrhea, dermatitis, fever, and chills [see Warnings and Precautions ( 5.10 )]. Nervous system: tremor, seizure. Renal: renal impairment and/or failure. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution as a Two-Day Split-Dosing and One-Day Evening Only Dosing Regimen was evaluated in two randomized, active-controlled, multicenter, investigator-blinded clinical trials in adult patients scheduled to have an elective colonoscopy [see Clinical Studies (14) ] . The safety analysis for Study 1 included 359 adult patients ranging in age from 18 to 88 years (mean age 59), with 52% female and 48% male patients. The safety analysis for Study 2 included 340 adult patients ranging in age from 21 to 76 years (mean age 53), with 53% male and 47% female patients. Tables 1 and 2 display adverse reactions reported in at least 2% and 5% of patients in either treatment group in Study 1 and Study 2, respectively. Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials. Table 1: Common Adverse Reactions Reported in at least 2% of patients in either treatment group in Patients Undergoing Colonoscopy in Study 1 Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution Two-Day Split Dosing Regimen (N=180) 4 Liter PEG + Electrolytes Solution (N=179) Malaise 19% 18% Nausea 14% 20% Abdominal pain 13% 15% Vomiting 8% 13% Upper abdominal pain 6% 6% Dyspepsia 3% 1% Table 2: Common Adverse Reactions Reported in at least 5% of patients in either treatment group Patients were specifically asked about the occurrence of the following symptoms: shivering, anal irritations, abdominal bloating or fullness, sleep loss, nausea, vomiting, weakness, hunger sensation, abdominal cramps or pain, thirst sensation, and dizziness. in Patients Undergoing Colonoscopy in Study 2 Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution One-Day Evening Only Dosing Regimen (N=169) 90 mL Oral Sodium Phosphate Solution (N=171) Abdominal distension 60% 41% Anal discomfort 51% 52% Thirst 47% 65% Nausea 47% 47% Abdominal pain 39% 32% Sleep disorder 35% 29% Rigors 34% 30% Hunger 30% 71% Malaise 27% 53% Vomiting 7% 8% Dizziness 7% 18% Headache 2% 5% Hypokalemia 0% 6% Hyperphosphatemia 0% 6% 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution or other PEG-based products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema, asystole, acute pulmonary edema and syncope, and dehydration. Gastrointestinal: upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]. Hypersensitivity reactions: anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness, rhinorrhea, dermatitis, fever, and chills [see Warnings and Precautions ( 5.10 )]. Nervous system: tremor, seizure. Renal: renal impairment and/or failure.

Drugs that increase risk for fluid and electrolyte imbalance. ( 7.1 ) 7.1 Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities Use caution when prescribing Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution 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, seizures, arrhythmias, or QT prolongation 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 Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution can reduce the absorption of other co-administered drugs. Administer oral medications at least 1 hour before the start of administration of each dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Dosage and Administration ( 2.1 )] . 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Warnings and Precautions ( 5.5 , 5.6 )]. 7.1 Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities Use caution when prescribing Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution 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, seizures, arrhythmias, or QT prolongation 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 Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution can reduce the absorption of other co-administered drugs. Administer oral medications at least 1 hour before the start of administration of each dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Dosage and Administration ( 2.1 )] .