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Format PDRT Physicians’ Desk ReferenceT Index Electronic PROOF 〈 For publisher use only 〉 IMPORTANT: Check below to indicate the status of proof. Please print clearly in blue or black ink. All proofs must carry an authorized signature. Space for this copy will be billed at prevailing rates. The Publisher reserves the right to reproduce, offer and make available, the listings electronically as well as in print and other media. □ OK to Publish 〈 No Proof Required 〉 □ OK With Corrections 〈 No Proof Required 〉 Signature □ Revise □ Cancel 〈 Show Proof 〉 Date For Publisher Use Only M Proof M Disk Supplied M Completely Revised M Phone In M GEN M PD FLEET® BISACODYL LAXATIVES: ENEMA AND TABLETS Fleet PDR Main DATE OF RUN 06/25/2014 TIME OF RUN 17:0 PROCESSING SECTION 2880 SUB-PROCESSING SECTION 0133 SETID ff0ad4b3-d6f3-4329-be6f-1b515bfb4d99 PAGE 1 cont’d Jun 25 2014 16:59:38 OTC A STIMULANT LAXATIVE COMPOSITION FLEET® Bisacodyl Enema - 10 mg bisacodyl enema solution in a 37-mL ready-to-use squeeze bottle which is not made with natural rubber latex, with a 2-inch, prelubricated Comfortip®. It is disposable after a single use. FLEET® Stimulant Laxative Tablets - Enteric-coated 5 mg bisacodyl each tablet. ACTION AND USES Bisacodyl is a stimulant laxative given either orally or rectally, acting directly on the colonic mucosa where it stimulates sensory nerve endings to produce parasympathetic reflexes resulting in increased peristaltic contractions of the colon. The contact action of the drug is restricted to the colon, and motility in the small intestine is not appreciably influenced. FLEET® Stimulant Laxative Tablets usually work within 6-12 hours, and the FLEET® Bisacodyl Enema produces a bowel movement within 5–20 minutes. Bisacodyl is useful as a laxative for relief of occasional constipation and in bowel cleansing in preparation for x-ray or endoscopic examination. Bisacodyl may be used as a laxative in postoperative, antepartum, or postpartum care or in preparation for delivery under guidance of a healthcare professional. Store at controlled room temperature 68-77°F (20-25°C). WARNINGS: Do not administer Fleet® Bisacodyl Enema to children under 12 years of age. GENERAL LAXATIVE WARNINGS INFORMATION FOR PATIENT Ask a doctor before using any laxative if you have • abdominal pain, nausea or vomiting • a sudden change in bowel habits lasting more than 2 weeks • already used a laxative for more than 1 week Stop using this product and consult a doctor if you have • rectal bleeding • no bowel movement within 20 minutes of using the rectal product • if constipation continues after one week of use These symtoms may be signs of a serious condition. All bisacodyl products may cause • abdominal discomfort • faintness • mild cramps Rectal products may also cause rectal burning. As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product. Keep this and all drugs out of the reach of children to prevent accidental ingestion. In case of accidental overdose or ingestion, seek professional assistance or contact a Poison Control Center right away. 001 Format PDRT Physicians’ Desk ReferenceT Index Electronic PROOF 〈 For publisher use only 〉 Fleet PDR Main DATE OF RUN 06/25/2014 TIME OF RUN 17:0 PROCESSING SECTION 2880 SUB-PROCESSING SECTION 0133 SETID ff0ad4b3-d6f3-4329-be6f-1b515bfb4d99 PAGE 2 cont’d Jun 25 2014 16:59:38 DOSAGE AND ADMINISTRATION Enema SHAKE BEFORE USING. Dosage: Adults and children 12 years of age and over: Use one 1.25 fl. oz. bottle (30-mL delivered dose) as a single daily dose (per 24 hours). Children under 12 years of age: DO NOT USE. Positions for using this enema: • Left-side position: Lie on left side with knee bent, and arms resting comfortably. • Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably. Fleet® Bisacodyl Enema should be used at room temperature. How to use this enema: • Shake bottle well before removing protective shield • REMOVE ORANGE PROTECTIVE SHIELD FROM ENEMA COMFORTIP® BEFORE INSERTING. • With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus. • DO NOT FORCE THE ENEMA TIP INTO RECTUM AS THIS CAN CAUSE INJURY. • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed. A small amount of liquid will remain in the bottle after squeezing. • Remove Comfortip® from rectum and discard bottle. • Maintain position until urge to evacuate is strong (usually 5 to 20 minutes). Do not retain enema solution for more than 20 minutes. • Stop using this product and consult a doctor if you don’t have a bowel movement within 20 minutes of using this product. The diaphragm at the base of the nozzle prevents reflux and assures controlled flow of the enema solution. IMPORTANT: FLEET® Bisacodyl Enema IS NOT INTENDED FOR ORAL CONSUMPTION in any dosage size. PROFESSIONAL ADMINISTRATION FLEET® Bisacodyl Enema should not be used in children under 12 years of age. Careful consideration of the use of enemas in children in general is recommended. Proper and safe use of FLEET® enemas also requires that the products be administered according to the directions. Healthcare professionals should remember when administering the product to gently insert the enema into the rectum with the tip pointing toward the navel. Insertion may be made easier by having the patient bear down as if having a bowel movement. Care during insertion is necessary due to lack of sensory innervation of the rectum and due to the possibility of bowel perforation. Once inserted, squeeze the bottle until nearly all the liquid is expelled. If resistance is encountered on insertion of the nozzle or in administering the solution, the procedure should be discontinued. Forcing the enema can result in perforation and/or abrasion of the rectum. 002 Format PDRT Physicians’ Desk ReferenceT Index Electronic PROOF 〈 For publisher use only 〉 Fleet PDR Main DATE OF RUN 06/25/2014 TIME OF RUN 17:0 PROCESSING SECTION 2880 SUB-PROCESSING SECTION 0133 SETID ff0ad4b3-d6f3-4329-be6f-1b515bfb4d99 PAGE 3 end Jun 25 2014 16:59:38 Tablets Adults and children 12 years of age and over: Take 1 to 3 tablets (usually 2) in a single dose once daily (per 24 hours). Children 6 to under 12 years of age: Take 1 tablet once daily (per 24 hours). Children under 6 years of age: Consult a physician. Expect results in 6–12 hours if taken at bedtime or within 6 hours if taken before breakfast. Swallow tablets whole. Do not chew or crush tablets. Do not administer tablets within 1 hour after taking an antacid, milk, or milk products. HOW SUPPLIED Enema FLEET® Bisacodyl Enema is supplied in a 1.25 fl. oz. (37mL) ready-to-use squeeze bottle. NDC code: 0132070336. Tablets FLEET® Stimulant Laxative Tablets are supplied in cartons of 25 tablets (5 mg bisacodyl in each tablet) wrapped in a foil seal. NDC code: 0132070402 IS THIS PRODUCT OTC? Yes. QUESTIONS? Call 1-866-255-6960 or visit www.fleetlabs.com 003 ESTIMATED LENGTH OF PRODUCT 28800133 IS 14.611 INCHES