{"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 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=\"253.455px\"> <col/> <col/> <tbody> <tr> <td styleCode=\"     Botrule     \">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     \">children 6 to under 12 years</td> <td styleCode=\"     Botrule         Lrule     \">take 1 tablet in a single daily dose</td> </tr> <tr> <td>children under 6 years</td> <td styleCode=\"    Lrule     \">ask a doctor</td> </tr> </tbody> </table>"],"effective_time":"20190801","id":"c2ac20c2-20ac-4a0d-86ba-e90c552611ba","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 temporary 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 (1-800-222-1222) right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mg NDC 71610-219 - Bisacodyl EC, USP 5 mg Bottle Label 5 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stimulant laxative"],"questions":["Questions or comments? (800)-616-2471"],"set_id":"b5e1a7f8-17ef-4d67-aeea-879603f800a5","spl_product_data_elements":["Bisacodyl Bisacodyl BISACODYL DEACETYLBISACODYL ACACIA CALCIUM CARBONATE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE ANHYDROUS LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED Polyvinyl Acetate Phthalate POVIDONE PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE WATER SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 5"],"spl_unclassified_section":["Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 5 mg 4 71610-219-04 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20190801JH Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["<table border=\"0\" cellpadding=\"1\" cellspacing=\"1\" width=\"28%\"> <colgroup> <col width=\"10%\"/> <col/> </colgroup> <tbody> <tr styleCode=\"Toprule\"> <td valign=\"bottom\" align=\"center\" styleCode=\"bold\">Count</td> <td valign=\"bottom\" align=\"center\"> <content styleCode=\"bold\">5 mg</content> </td> </tr> <tr> <td valign=\"bottom\" align=\"center\">4</td> <td align=\"center\">71610-219-04</td> </tr> </tbody> </table>"],"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":"2","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 you may have 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 (1-800-222-1222) 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 you may have stomach discomfort, faintness and cramps"]}