{"active_ingredient":["Active ingredient (in each tablet) Bisacodyl USP, 5 mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks"],"do_not_use":["Do not use if you cannot swallow without chewing."],"dosage_and_administration":["Directions do not take more than directed take with a glass of water adults and children 12 years and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years take 1 tablet in a single daily dose children under 6 years ask a doctor"],"dosage_and_administration_table":["<table width=\"450px\" cellspacing=\"0\"> <col/> <col/> <tbody> <tr> <td styleCode=\" Botrule Rrule\">adults and children 12 years and over</td> <td styleCode=\" Botrule Lrule\">take 1 to 3 tablets in a single daily dose</td> </tr> <tr> <td styleCode=\" Botrule Toprule Rrule\">children 6 to under 12 years</td> <td styleCode=\" Botrule Toprule Lrule\">take 1 tablet in a single daily dose</td> </tr> <tr> <td styleCode=\" Toprule Rrule\">children under 6 years</td> <td styleCode=\" Toprule Lrule\">ask a doctor  </td> </tr> </tbody> </table>"],"effective_time":"20250331","how_supplied":["HOW SUPPLIED Bisacodyl USP, 5 mg NDC: 71335-2010-0: 25 Tablets in a BOTTLE NDC: 71335-2010-1: 30 Tablets in a BOTTLE NDC: 71335-2010-2: 2 Tablets in a BOTTLE NDC: 71335-2010-3: 3 Tablets in a BOTTLE NDC: 71335-2010-4: 4 Tablets in a BOTTLE NDC: 71335-2010-5: 10 Tablets in a BOTTLE NDC: 71335-2010-6: 90 Tablets in a BOTTLE NDC: 71335-2010-7: 8 Tablets in a BOTTLE NDC: 71335-2010-8: 100 Tablets in a BOTTLE NDC: 71335-2010-9: 20 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504"],"id":"42ebd7ff-4d1b-4c81-9374-43cbef0dad3a","inactive_ingredient":["Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate"],"indications_and_usage":["Uses for relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["505G(a)(3)"],"brand_name":["Bisacodyl"],"generic_name":["BISACODYL"],"manufacturer_name":["Bryant Ranch Prepack"],"nui":["N0000009371","N0000175812","N0000009871"],"original_packager_product_ndc":["0904-6748"],"package_ndc":["71335-2010-0","71335-2010-1","71335-2010-2","71335-2010-3","71335-2010-4","71335-2010-5","71335-2010-6","71335-2010-7","71335-2010-8","71335-2010-9"],"pharm_class_epc":["Stimulant Laxative [EPC]"],"pharm_class_pe":["Increased Large Intestinal Motility [PE]","Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["71335-2010"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308753"],"spl_id":["42ebd7ff-4d1b-4c81-9374-43cbef0dad3a"],"spl_set_id":["71dea737-3fde-461f-958d-3a39ebdbf1ae"],"substance_name":["BISACODYL"],"unii":["10X0709Y6I"]},"package_label_principal_display_panel":["Bisacodyl 5mg Tablet Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stimulant laxative"],"questions":["Questions or comments? 1-800-426-9391"],"set_id":"71dea737-3fde-461f-958d-3a39ebdbf1ae","spl_product_data_elements":["Bisacodyl Bisacodyl BISACODYL DEACETYLBISACODYL ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE ANHYDROUS LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ACETATE PHTHALATE POVIDONE, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE WATER SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 5"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week"],"storage_and_handling":["Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number"],"version":"104","warnings":["Warnings Do not use if you cannot swallow without chewing. Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks When using this product do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk it may cause stomach discomfort, faintness, and cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk it may cause stomach discomfort, faintness, and cramps"]}