{"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":"20250122","id":"2c47ce1d-e75d-4bc7-e063-6394a90a5c1e","inactive_ingredient":["Inactive ingredients Colloidal silicon dioxide, Hypromellose-5, Magnesium stearate, Maltodextrin, Methacrylic acid, Microcrystalline cellulose, Neelicert FD&C Yellow 10 Al Lake, Neelicert FD&C Yellow 6 Al Lake, PEG 400, Purified Water, Sodium Starch Glycolate, Talc, Titanium Dioxide, 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":["Laxative"],"generic_name":["BISACODYL"],"is_original_packager":[true],"manufacturer_name":["Advanced Rx LLC"],"nui":["N0000009371","N0000175812","N0000009871"],"package_ndc":["80513-409-20"],"pharm_class_epc":["Stimulant Laxative [EPC]"],"pharm_class_pe":["Increased Large Intestinal Motility [PE]","Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["80513-409"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308753"],"spl_id":["2c47ce1d-e75d-4bc7-e063-6394a90a5c1e"],"spl_set_id":["af2dbf50-f7ac-486d-a636-f8f77d7c880f"],"substance_name":["BISACODYL"],"unii":["10X0709Y6I"]},"package_label_principal_display_panel":["NDC 80513-409-20 *Compare to Dulcolax ® Laxative Tablets Active Ingredient Laxative Bisacodyl USP 5 mg Gentle Predictable Overnight Relief 200 Comfort Coated Tablets *This product is not manufactured or distributed by the owner of the registered trademark Dulcolax ®. labels"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stimulant laxative"],"questions":["Questions or comments? 1-800-630-8895"],"set_id":"af2dbf50-f7ac-486d-a636-f8f77d7c880f","spl_product_data_elements":["Laxative Bisacodyl SILICON DIOXIDE HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE MALTODEXTRIN METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE D&C YELLOW NO. 10 ALUMINUM LAKE FD&C YELLOW NO. 6 ALUMINUM LAKE POLYETHYLENE GLYCOL 400 WATER SODIUM STARCH GLYCOLATE TYPE A TALC TITANIUM DIOXIDE TRIETHYL CITRATE BISACODYL DEACETYLBISACODYL B5"],"spl_unclassified_section":["Distributed by ADVANCED RX LLC 1942 NE 163rd St.North Miami Beach, FL 33162 U.S.A."],"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 IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity use by expiration date on package"],"version":"1","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"]}