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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

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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 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 72.30 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.
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