PEG-3350 and Electrolytes

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 PEG-3350 and Electrolytes for Oral Solution were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a 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)]. Most common adverse reactions are: nausea, abdominal fullness, bloating abdominal cramps, vomiting and anal irritation. To report SUSPECTED ADVERSE REACTIONS, contact Affordable Pharmaceuticals, LLC at 1-800-514-5617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

4 CONTRAINDICATIONS PEG-3350 and Electrolytes 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 )] Toxic colitis or toxic megacolon Gastric retention Ileus Hypersensitivity to any component of PEG-3350 and Electrolytes for Oral Solution [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 PEG-3350 and Electrolytes for Oral Solution ( 4 , 5.8 )

11 DESCRIPTION PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP Sodium Sulfate, USP The chemical name is Na 2 SO 4 . The average Molecular Weight is 142.04. The structural formula is: Sodium Bicarbonate, USP The chemical name is NaHCO 3 . The average Molecular Weight is 84.01. The structural formula is: Sodium Chloride, USP The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is: Na + Cl - Potassium Chloride, USP The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is: K-Cl PEG Chemical Structure Na2SO4 Chemical Structure NaHCO3 Chemical Structure

2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.1 ): Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and Electrolytes for Oral Solution. Reconstitute PEG-3350 and Electrolytes for Oral Solution with water prior to ingestion. Do not take oral medications within 1 hour before the start or during administration of PEG-3350 and Electrolytes for Oral Solution. ( 2.1 ) Do not take other laxatives while taking PEG-3350 and Electrolytes for Oral Solution. Consume only clear liquids; avoid red and purple liquids. Consume water or other clear liquids up until 2 hours before the time of the colonoscopy. Do not consume solid food within 2 hours before starting PEG-3350 and Electrolytes for Oral Solution. Adult Dosing Regimen ( 2.2 ): On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting PEG-3350 and Electrolytes for Oral Solution. Begin the recommended dosage regimen for PEG-3350 and Electrolytes for Oral Solution early in the evening on the day before colonoscopy. Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 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 PEG-3350 and Electrolytes for Oral Solution [see Warnings and Precautions (5.1)] . Reconstitute PEG-3350 and Electrolytes for Oral Solution with water prior to ingestion, do not take undissolved PEG-3350 and Electrolytes for Oral Solution [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 1 hour before the start of or during administration of PEG-3350 and Electrolytes for Oral Solution [see Drug Interactions (7.2)] . Do not take other laxatives while taking PEG-3350 and Electrolytes for Oral Solution [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 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration. Do not consume solid food within 2 hours before starting PEG-3350 and Electrolytes for Oral Solution. For the best results, do not consume solid food for 3 to 4 hours before drinking the solution. If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue PEG-3350 and Electrolytes for Oral Solution until the symptoms abate. 2.2 Dosage Regimen Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting PEG-3350 and Electrolytes for Oral Solution. Begin the recommended dosage regiment for PEG-3350 and Electrolytes for Oral Solution early in the evening on the day before colonoscopy. Instruct patients to take PEG-3350 and Electrolytes for Oral Solution in conjunction with clear liquids as follows: 4 Liter Jug Fill the supplied container containing the PEG-3350 and Electrolytes for Oral Solution 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 a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour. After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion. Administration via a Nasogastric Tube For patients with a nasogastric tube, administer the reconstituted PEG-3350 and Electrolytes for Oral Solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).

1 INDICATIONS AND USAGE PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. PEG-3350 and Electrolytes for Oral Solution is a 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 )

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 PEG-3350 and Electrolytes 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, 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 PEG-3350 and Electrolytes for Oral Solution can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of PEG-3350 and Electrolytes for Oral Solution [see Dosage and Administration ( 2.1 )] . 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and PEG-3350 and Electrolytes 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 PEG-3350 and Electrolytes for Oral Solution [see Warnings and Precautions ( 5.5 )] .

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 a watery stool. 12.2 Pharmacodynamics PEG-3350 and Electrolytes for Oral Solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours. 12.3 Pharmacokinetics The pharmacokinetics of PEG3350 following administration of PEG-3350 and Electrolytes for Oral Solution were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

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 a watery stool.

12.2 Pharmacodynamics PEG-3350 and Electrolytes for Oral Solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

12.3 Pharmacokinetics The pharmacokinetics of PEG3350 following administration of PEG-3350 and Electrolytes for Oral Solution were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

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3 DOSAGE FORMS AND STRENGTHS For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 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 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride and 3 g flavoring ingredients per 4 liters.

PEG-3350 and Electrolytes Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 SODIUM SULFATE ANHYDROUS SODIUM CATION SULFATE ION SODIUM BICARBONATE SODIUM CATION BICARBONATE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION PEG-3350 and Electrolytes Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 SODIUM SULFATE ANHYDROUS SODIUM CATION SULFATE ION SODIUM BICARBONATE SODIUM CATION BICARBONATE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION PINEAPPLE

NDA019011

PEG-3350 and Electrolytes

Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride

10572-100

HUMAN PRESCRIPTION DRUG

ORAL

Principal Display Panel - Bottle Label NDC 10572-100-01 PEG-3350 and Electrolytes for Oral Solution Rx only Principal Display Panel - Bottle Label

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

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use). Instruct patients: To reconstitute PEG-3350 and Electrolytes for Oral Solution with water prior to ingestion. Not to take other laxatives while they are taking PEG-3350 and Electrolytes for Oral Solution. Not to take oral medications within 1 hour before the start or during the administration of PEG-3350 and Electrolytes for Oral Solution. 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 2 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 a hypersensitivity reaction [see Warnings and Precautions ( 5.8 )] . Distributed by Affordable Pharmaceuticals, LLC, Braintree, MA 02185

Medication Guide PEG-3350 and Electrolytes for Oral Solution (PEG-3350 and i-lek-truh-lahyts for oral solution) Read this Medication Guide before you start taking PEG-3350 and Electrolytes for Oral Solution. 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 I should know about PEG-3350 and Electrolytes for Oral Solution? PEG-3350 and Electrolytes for Oral Solution 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 a seizure. kidney problems. Your chance of having fluid loss and changes in body salts with PEG-3350 and Electrolytes for Oral Solution is higher if you: have heart problems. have kidney problems. take water pills or non-steroidal anti-inflammatory drugs (NSAIDS). Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking PEG-3350 and Electrolytes for Oral Solution: 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 PEG-3350 and Electrolytes for Oral Solution” for more information about side effects. What is PEG-3350 and Electrolytes for Oral Solution? PEG-3350 and Electrolytes for Oral Solution is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. PEG-3350 and Electrolytes for Oral Solution cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if PEG-3350 and Electrolytes for Oral Solution is safe and effective in children. Who should not take PEG-3350 and Electrolytes for Oral Solution? Do not takePEG-3350 and Electrolytes for Oral Solution 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 PEG-3350 and Electrolytes for Oral Solution. See the end of this Medication Guide for a complete list of ingredients in PEG-3350 and Electrolytes for Oral Solution. What should I tell my healthcare provider before taking PEG-3350 and Electrolytes for Oral Solution? Before you take PEG-3350 and Electrolytes for Oral Solution, tell your healthcare provider if you: have heart problems. have stomach or bowel problems. have ulcerative colitis. have problems with swallowing or gastric reflux. have a history of seizures. are withdrawing from drinking alcohol. have a low blood salt (sodium) level. have kidney problems. have any other medical conditions. are pregnant. It is not known if PEG-3350 and Electrolytes for Oral Solution 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 PEG-3350 and Electrolytes for Oral Solution passes into your breast milk. You and your healthcare provider should decide if you will take PEG-3350 and Electrolytes for Oral Solution while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PEG-3350 and Electrolytes for Oral Solution may affect how other medicines work. Do not take medicines by mouth within 1 hour of starting PEG-3350 and Electrolytes for Oral Solution or after you start taking PEG-3350 and Electrolytes for Oral Solution. 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 PEG-3350 and Electrolytes for Oral Solution with starch-based thickeners. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take PEG-3350 and Electrolytes for Oral Solution? You must read, understand, and follow these instructions to take PEG-3350 and Electrolytes for Oral Solution the right way. Take PEG-3350 and Electrolytes for Oral Solution 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 PEG-3350 and Electrolytes for Oral Solution. Do not take undissolved PEG-3350 and Electrolytes for Oral Solution 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 PEG-3350 and Electrolytes for Oral Solution. Drink reconstituted solution at a rate of 8 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 2 hours before taking PEG-3350 and Electrolytes for Oral Solution. You may eat a light breakfast 2 hours before taking PEG-3350 and Electrolytes for Oral Solution. For best results, do not consume solid food for 3 to 4 hours before drinking PEG-3350 and Electrolytes for Oral Solution. Drink only water and clear liquids: ○ the day before your colonoscopy ○ while taking PEG-3350 and Electrolytes for Oral Solution ○ after taking PEG-3350 and Electrolytes for Oral Solution until 2 hours before your colonoscopy. Drink clear liquids before, during, and after you take PEG-3350 and Electrolytes for Oral Solution to avoid fluid loss (dehydrated). Examples of clear liquids are: ○ water ○ clear broth ○ clear fruit juices without pulp including ○ clear soda apple, white grape, or white cranberry ○ gelatin (without added fruit or ○ strained limeade or lemonade topping) ○ coffee or tea (Do not use any dairy ○ popsicles without pieces of or non-dairy creamer) 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 PEG-3350 and Electrolytes for Oral Solution? PEG-3350 and Electrolytes for Oral Solution can cause serious side effects, including: See Section “What is the most important information I should know about PEG-3350 and Electrolytes for Oral Solution?” changes in certain blood tests. Your healthcare provider may do blood tests before and after you take PEG-3350 and Electrolytes for Oral Solution 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 PEG-3350 and Electrolytes for Oral Solution include: • nausea • chest x-ray that shows water in the • stomach (abdominal) fullness lungs (infiltrate) after vomiting or • bloating inhaling food or liquid (aspirate). • stomach (abdominal) cramps • anal irritation • vomiting • esophageal bleeding 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 PEG-3350 and Electrolytes for Oral Solution. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store PEG-3350 and Electrolytes for Oral Solution? Store PEG-3350 and Electrolytes for Oral Solution in a sealed container at room temperature, between 59ºF to 86°F (15ºC to 30°C). Store mixed (reconstituted) solution of PEG-3350 and Electrolytes for Oral Solution at 36° to 46°F (2°C to 8°C). Do not freeze. Use mixed (reconstituted) solution of PEG-3350 and Electrolytes for Oral Solution within 48 hours. After 48 hours, throw away (discard) any mixed (reconstituted) solution of PEG-3350 and Electrolytes for Oral Solution that is not used. Keep PEG-3350 and Electrolytes for Oral Solution and all medicines out of the reach of children. General information about the safe and effective use of PEG-3350 and Electrolytes for Oral Solution. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PEG-3350 and Electrolytes for Oral Solution for a condition for which it was not prescribed. Do not give PEG-3350 and Electrolytes for Oral Solution to other people, even if they are going to have the same procedure you are. It may harm them. This Medication Guide summarizes important information about PEG-3350 and Electrolytes for Oral Solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals. What are the ingredients in PEG-3350 and Electrolytes for Oral Solution? PEG-3350 and Electrolytes for Oral Solution comes in a 4-liter jug with PEG-3350 and Electrolytes for Oral Solution powder. Active ingredients: Powder for solution: polyethylene glycol 3350, sodium sulfate (anhydrous), sodium bicarbonate, sodium chloride, and potassium chloride. Inactive Ingredients: Pineapple Flavored PEG-3350 and Electrolytes for Oral Solution only (natural and artificial pineapple flavor powder, maltodextrin, gum arabic, sodium saccharin, silicon dioxide) Affordable Pharmaceuticals, LLC Braintree, MA 02185, USA For more information go to www.affordablepharma.com or call 1-800-514-5617. This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2021

8.5 Geriatric Use Clinical studies of PEG-3350 and Electrolytes for Oral Solution 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.

8.3 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 PEG-3350 and Electrolytes for Oral Solution is administered to a nursing woman.

8.4 Pediatric Use Safety and effectiveness of PEG-3350 and Electrolytes for Oral Solution in pediatric patients have not been established.

8.1 Pregnancy Animal reproduction studies have not been conducted with PEG-3350 and Electrolytes for Oral Solution. It is also not known whether PEG-3350 and Electrolytes for Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PEG-3350 and Electrolytes for Oral Solution should be given to a pregnant woman only if clearly needed.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Animal reproduction studies have not been conducted with PEG-3350 and Electrolytes for Oral Solution. It is also not known whether PEG-3350 and Electrolytes for Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PEG-3350 and Electrolytes for Oral Solution should be given to a 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 PEG-3350 and Electrolytes for Oral Solution is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of PEG-3350 and Electrolytes for Oral Solution in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of PEG-3350 and Electrolytes for Oral Solution 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 PEG-3350 and Electrolytes for Oral Solution 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 PEG-3350 and Electrolytes for Oral Solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions ( 5.4 )] .

16 HOW SUPPLIED/STORAGE AND HANDLING PEG-3350 and Electrolytes for Oral Solution is supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 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. PEG-3350 and Electrolytes for Oral Solution 4 Liter Disposable Jug NDC 10572-100-01 Pineapple Flavor PEG-3350 and Electrolytes for Oral Solution 4 Liter Disposable Jug NDC 10572-101-01 Storage Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of PEG-3350 and Electrolytes for Oral Solution at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)] .

Storage Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of PEG-3350 and Electrolytes for Oral Solution at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)] .