FLEET® PHOSPHO-SODA® EZ-PREPTM OTC WARNINGS for PATIENTS Bowel Cleansing System DO NOT EXCEED RECOMMENDED DOSE UNLESS DIRECTED by a PHYSICIAN

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FLEET® PHOSPHO-SODA® EZ-PREPTM OTC WARNINGS FOR PATIENTS Bowel Cleansing System DO NOT EXCEED RECOMMENDED DOSE UNLESS DIRECTED BY A PHYSICIAN. SERIOUS SIDE EFFECTS MAY OCCUR FROM EXCESS DOSAGE. IF THERE IS NO BOWEL MOVEMENT AFTER SIX HOURS, CONTACT A PHYSICIAN, AS DEHYDRATION AND CONSEQUENT SERIOUS SIDE EFFECTS COULD OCCUR. DESCRIPTION COMPOSITION OF FLEET® PHOSPHO-SODA® EZ-PREPTM BOWEL CLEANSING SYSTEM During bowel preparation you will lose significant amounts of fluid. THIS IS NORMAL. It is very important that you replace this fluid to prevent dehydration. Fleet® Phospho-soda® EZ-PrepTM contains: Early symptoms of dehydration include feeling thirsty, dizziness, urinating less often than normal, or vomiting. These symptoms may be signs of serious 1. Two Bottles of Fleet® Phospho-soda® Oral Saline Laxative, Unflavored – Dose 1, 45 mL (1.5 fl.oz.) and Dose 2, 30 mL (1.0 fl.oz.). problems. Drink as much extra liquids as you can to help replace the fluids you are losing during bowel movements. Drinking large amounts of clear liquids Net contents 75 mL (2.5 fl.oz.). Active ingredients: each 15 mL contains monobasic sodium phosphate monohydrate 7.2g and also helps ensure that your bowel will be clean for the examination or procedure. dibasic sodium phosphate heptahydrate 2.7g. 2. Two Lemonade Flavor Packets net contents 0.07 oz. each. Phenylketonurics: contains phenylalanine. DO NOT USE if you have congestive heart failure, if you have serious kidney problems, or in children under 18 years of age. 3. One 12 fl.oz. mixing cup 4. One Patient instruction sheet Ask a doctor before use if you are under a doctor’s care for any medical condition, are on a low-salt diet or are pregnant or nursing a baby. Ask a doctor or pharmacist before use if you are taking any other prescription or non-prescription drugs. Ask a doctor before using any laxative if you have abdominal Fleet® Phospho-soda® (belly) pain, nausea, or vomiting, have a change in your daily bowel movements that lasts more than 2 weeks, or have already used another laxative daily for constipation for more than 1 week. Stop using this product and consult a doctor if you have any rectal bleeding, do not have a bowel movement within 6 hours Composition of taking Phospho-soda® or have any symptoms that your body is losing more fluids than you are drinking. This is called dehydration. Early symptoms of Each 15 mL of unflavored FLEET® Phospho-soda® oral saline laxative contains 7.2 g monobasic sodium phosphate monohydrate and 2.7 g dibasic sodium dehydration include feeling thirsty, dizziness, urinating less often than normal, or vomiting. These symptoms may be signs of serious problems. phosphate heptahydrate in a stable, aqueous solution. Keep this and all drugs out of the reach of children. In case of overdose or accidental ingestion, seek professional assistance or contact a ELEMENTAL AND ELECTROLYTIC CONTENT: Poison Control Center right away. mEq Phosphate (PO4) per 15 mL 186.75 mEq Sodium (Na) per�� 15 mL �7�2�.��30 DOSAGE AND ADMINISTRATION The first dose consists of one 45-mL bottle (1.5 fl.oz.) of Fleet® Phospho-soda® oral saline laxative mixed with 12 fl.oz. of water and one flavor packet. mg Sodium (Na) per�� 15 mL ��1668 Immediately drink at least 1 more full glass (12 fl.oz.) of clear liquids. Drink at least 2 more full mixing cups (12 fl.oz. each) or glasses of clear liquids. The mmole Phosphorus (P) per 15 mL 62.25 second dose consists of one 30 mL bottle (1.0 fl.oz.) of Fleet® Phospho-soda® oral saline laxative mixed with 12 fl.oz. of water and one flavor packet. ACTIONS Immediately drink at least 1 more full glass (12 fl.oz.) of clear liquids. After your exam, drink plenty of liquids to prevent dehydration. The doctor should also TM prescribe the timing of the two doses of diluted Fleet® Phospho-soda® so the doses are separated by 10 to 12 hours. The recommended intervals are 7 p.m. Fleet® Phospho-soda® EZ-Prep is a bowel cleansing system. the day before the examination and 6 a.m. the morning of the examination. INDICATIONS AND USES For use as part of a bowel cleansing regimen in preparing the colon for colonoscopy, other endoscopic and radiologic examination and surgery. See DOSAGE Additional bowel preparation instruction sheets are available by calling 1-888-999-9711 or visiting www.ez-prep.com. AND ADMINISTRATION. This product generally produces a bowel movement in 30 minutes to 6 hours. * DO NOT TAKE MORE THAN 45 ML (1.5 fl.oz.) PER DOSE. NEVER take more than 1 bottle at one time.

PROFESSIONAL USE WARNINGS Medical procedures use only when directed by a doctor: FLEET® Phospho-soda® has been rarely associated with severe and potentially fatal cases of electrolyte disorders in elderly patients. The benefit/risk ratio of Fleet® Phospho-soda® needs to be carefully considered before initiating treatment in this at-risk population. Dose 1 Special attention should be taken when prescribing Fleet® Phospho-soda® to any patient with regard to known contraindications and the Ages (years) Step 1 Step 2 Step 3 Step 4 Step 5 importance of adequate hydration and, in at-risk populations (see below), the importance of also obtaining baseline and post-treatment Adults and children Add powder from 1 Fill cup with 12 fl. Add the 1.5 fl. oz. Mix well and drink Immediately drink at least electrolyte levels. 18 years and over lemonade flavor oz. of cold water (45 mL) bottle all the contents in 1 more full glass (12 fl. oz.) Dose 1 packet to the provided (to the 12 fl. oz. (Dose 1, blue the mixing cup. of clear liquids. Do not use in patients with: Ages (years) mixingStep 1 cup . fillStep line). 2 Mix well. label).Step 3 Step 4 Step 5 • Congestive heart failure; ChildrenAdults and under children 18 DOAdd NOT powder USE from 1 Fill cup with 12 fl. Add the 1.5 fl. oz. Mix well and drink Immediately drink at least • Clinically significant impairment of renal function; years18 years and over lemonade flavor oz. of cold water (45 mL) bottle all the contents in 1 more full glass (12 fl. oz.) • Ascites; packet to the provided (to the 12 fl. oz. (Dose 1, blue the mixing cup. of clear liquids. • Known or suspected gastrointestinal obstruction; mixing cup. fill line). Mix well. label). Between doses • Megacolon (congenital or acquired); DrinkChildrenDose at 2least under 2 18more DOfull NOTmixing USE cups (12 fl.oz. each) or glasses of clear liquids. • Perforation; yearsAges (years) Step 1 Step 2 Step 3 Step 4 Step 5** • Ileus; or Drink as much additional clear liquids as you can. • Active inflammatory bowel disease. WaitAdults 10-12 and children hours between Add powder doses. from 1 Fill cup with 12 fl. Add the 1.0 fl. oz. Mix well and drink Immediately drink at least Do not use: 18 years and over lemonade flavor oz. of cold water (30 mL) bottle all the contents in 1 more full glass (12 fl. oz.) Dose 2 packet to the provided (to the 12 fl. oz. (Dose 2, orange the mixing cup. of clear liquids. • In children under the age of 18 years; Ages (years) mixingStep 1 cup . fillStep line). 2 Mix well. Steplabel). 3 Step 4 Step 5** • When nausea, vomiting or abdominal pain are present; or • If there is a hypersensitivity to the active ingredients or any of the excipients. ChildrenAdults and under children 18 DOAdd NOT powder USE from 1 Fill cup with 12 fl. Add the 1.0 fl. oz. Mix well and drink Immediately drink at least years18 years and over lemonade flavor oz. of cold water (30 mL) bottle all the contents in 1 more full glass (12 fl. oz.) Use with caution in patients who are: packet to the provided (to the 12 fl. oz. (Dose 2, orange the mixing cup. of clear liquids. • Elderly; mixing cup. fill line). Mix well. label). • Debilitated; Children under 18 DO NOT USE • Taking medications known to prolong the QT interval; years • On a low-salt diet; or • Pregnant or nursing a baby. And in patients with: ** Additional clear liquids may be taken until 3 hours before your procedure. • Heart disease; After your exam, drink plenty of liquids to prevent dehydration. • Acute myocardial infarction; • Unstable angina; HYDRATION AND DIET • An increased risk for underlying renal impairment; Encourage patients to drink large amounts of clear liquids to prevent dehydration while using this product and after the procedure. Drinking large amounts of • An increased risk for, and pre-existing, electrolyte disturbances, including patients with: clear liquids also helps ensure that the patient’s bowel will be clean for the procedure. (See “Clear Liquids Diet List” below). ■ Dehydration; During bowel preparation you will lose significant amounts of fluid. THIS IS NORMAL. It is very important that you replace this fluid to prevent dehydration. ■ Inability to take adequate oral fluid; Day before the exam - eat a regular breakfast. ■ Hypertension or other conditions in which the patients are taking drug products that may result in dehydration (see below); ■ Gastric retention; or DO NOT DRINK OR EAT ANYTHING COLORED RED OR PURPLE. ■ Colitis. • A colostomy or ileostomy. Low residue lunch (must be eaten before 2 p.m.). Do not eat anything that is not on this diet. Do not eat more than the allowed portions. Lunch may include any of the following items: In at-risk patients, including elderly patients, consider obtaining baseline and post-treatment sodium, potassium, calcium, chloride, bicarbonate, phosphate, blood urea nitrogen and creatinine values, and consider prescribing a 30 mL by 30 mL dosing regimen. There is a • Main entrée - choose one of the following: risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium; consequently, hypernatremia, hyperphosphatemia, • 3 oz. of skinless chicken, turkey, fish or seafood hypocalcemia, hypokalemia, and acidosis may occur. • 1 large or 2 medium eggs Nephrocalcinosis associated with transient renal insufficiency and renal failure has been very rarely reported in patients using sodium phosphates for bowel • 1 can of chicken noodle soup without vegetables cleansing; the majority of these reports occurred in elderly female patients taking drugs to treat hypertension or other drug products, such as diuretics • Vegetable/Fruit - choose one of the following: or NSAIDs, that may result in dehydration. Patients with conditions that may predispose to dehydration or those taking medications which may decrease • 1/2 cup applesauce glomerular filtration rate, such as diuretics, angiotensin converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBs), or non-steroidal anti- • 1/2 cup of cooked or canned vegetables without seeds. inflammatory drugs (NSAIDs) should be assessed for hydration status prior to use of purgative preparations and managed appropriately. • No corn.

TM • Bread - choose one of the following: Care should be taken to prescribe Fleet® Phospho-soda® EZ-Prep per recommendations with a particular attention to known contraindications and adequate • 1 white potato roll hydration (See DOSAGE AND ADMINISTRATION and INFORMATION FOR PATIENT). • 2 slices of white bread • 1 cup of cooked white rice or 1 cup of cooked pasta. Additional fluids by mouth are recommended with all bowel cleansing dosages. Encourage patients to drink large amounts of clear liquids to prevent • 1 small skinless potato dehydration. Inadequate fluid intake when using any effective purgative may lead to excessive fluid loss, possibly producing dehydration and hypovolemia. Dehydration and hypovolemia from purgation may be exacerbated by inadequate oral fluid intake, nausea, vomiting, loss of appetite, or use of diuretics, • Condiments - choose one of the following: angiotensin converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBs), non-steroidal anti-inflammatory drugs (NSAIDs), and lithium or other • 2 tsp. of soft tub margarine medications that may affect electrolyte levels, and may be associated with acute renal failure. There have been rare reports of acute renal failure with bowel • 1 tsp. mustard or mayonnaise purgatives, including sodium phosphates and PEG-3350. Drinking large amounts of clear liquids also helps ensure that the patient’s bowel will be clean for the • Dessert - choose one of the following: procedure. Instruct the patient to contact a physician if there is no bowel movement or retention after six hours as dehydration can occur. (See OVERDOSAGE • 4 vanilla wafers OR RETENTION below). • 1/4 cup pretzels • 1/2 cup sherbet During the intake of Fleet® Phospho-soda® the absorption of drugs from the gastrointestinal tract may be delayed or even completely prevented. The efficacy of regularly taken oral drugs (e.g. oral contraceptives, antiepileptic drugs, antidiabetics, antibiotics) may be reduced or completely absent. Any items from the "Clear Liquids Diet List" below:

Caution is also advised when taking medicines known to prolong the QT interval. CLEAR LIQUIDS DIET LIST: BEVERAGES: No other sodium phosphate preparations should be given concomitantly. • Water, tea or coffee (no milk or non-dairy creamer); sweeteners may be used There have been rare reports of hypersensitivity reactions (e.g., rash, urticaria, pruritus, tongue edema, throat tightness, and paresthesia of the lips) associated • Soft drinks (orange, ginger ale, cola, Sprite®, 7-Up®, etc.), Kool-Aid® with the use of marketed sodium phosphate products. •�� Oral�� Rehydration products, HydraLifeTM, Gatorade® • Strained fruit juices without pulp (apple, white grape, orange, lemonade, etc.) OVERDOSAGE OR RETENTION • Low-salt chicken or beef bouillon/broth Overdosage or retention may lead to severe electrolyte disturbances, including hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia, as well • Hard candies as dehydration and hypovolemia, with attendant signs and symptoms of these disturbances (such as metabolic acidosis, renal failure, and tetany). Certain • Jell-O® (lemon, lime, or orange; no fruit or toppings) severe electrolyte disturbances may lead to cardiac arrhythmia and death. The patient who has taken an overdose should be monitored carefully. Patients • Popsicles®, Italian ice (no ice cream, sherbets, or fruit bars) experiencing overdose have presented the following symptoms; dehydration, hypotension, tachycardia, bradycardia, tachypnoea, cardiac arrest, shock, Do NOT drink any alcoholic beverages. respiratory failure, dyspnoea, convulsions, ileus paralytic, anxiety, and pain. Overdoses can lead to elevated serum levels of sodium and phosphate and Do NOT drink or eat anything colored red or purple. decreased levels of calcium and potassium. In those cases, hypernatremia, hyperphosphatemia, hypocalcemia, hypokalemia, and acidosis may occur. Treatment of electrolyte imbalance may require immediate medical intervention with appropriate electrolyte and fluid replacement. How Supplied This complete, simple, convenient bowel-cleansing kit includes 1 45-mL bottle and 1 30-mL bottle of Fleet® Phospho-soda® oral saline laxative, 2 lemonade INFORMATION FOR PATIENT flavor packets, 1 mixing cup and patient instruction sheet. It is available in 12 units per case. The patient should be instructed to open and read directions at least two (2) days in advance of the examination. Instruct the patient to use this product for Fleet® Phospho-soda® EZ-PrepTM should not be confused with Fleet® Enema, a sodium phosphates disposable ready-to-use enema. Fleet® Enemas, Adult and bowel cleansing only as directed by a doctor, to discuss with the doctor the patient’s health and warnings about use of this product for bowel cleansing, to Children size, ARE NOT INTENDED FOR ORAL CONSUMPTION in any dosage size. follow the special directions from the doctor exactly and to take only the dose the doctor has recommended. The patient should be instructed to drink as much extra clear liquids as they can to replace the fluids lost during bowel movements: minimum 72 fl.oz. IS THIS PRODUCT OTC? Yes. Fleet® Phospho-soda® EZ-PrepTM is an OTC product, but it may be stocked behind the pharmacy counter. Patients should be directed to ask their pharmacists for Fleet® Phospho-soda® EZ-PrepTM bowel cleansing system.

Questions, call 1-888-999-9711 or visit www.ez-prep.com.