{"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=\"550px\"><col/><col/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\">adults and children 12 years and over</td><td styleCode=\" Botrule Toprule Lrule Rrule\">take 1 to 3 tablets in a single daily dose</td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\">children 6 to under 12 years</td><td styleCode=\" Botrule Toprule Lrule Rrule\">take 1 tablet in a single daily dose</td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\">children under 6 years</td><td styleCode=\" Botrule Toprule Lrule Rrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20260113","id":"e4f6f4a5-584f-41fc-a279-a0cb3474c2e9","inactive_ingredient":["Inactive ingredients acacia, calcium carbonate, carnauba wax, colloidal anhydrous silica, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methylparaben, polydextrose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, propylparaben, shellac glaze, simethicone, sodium benzoate, sodium bicarbonate, sodium lauryl sulfate, 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"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"nui":["N0000009371","N0000175812","N0000009871"],"package_ndc":["0904-6407-61"],"pharm_class_epc":["Stimulant Laxative [EPC]"],"pharm_class_pe":["Increased Large Intestinal Motility [PE]","Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["0904-6407"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308753"],"spl_id":["e4f6f4a5-584f-41fc-a279-a0cb3474c2e9"],"spl_set_id":["4fb4e630-875f-4c82-86d9-7696857e3c42"],"substance_name":["BISACODYL"],"unii":["10X0709Y6I"],"upc":["0309046407614"]},"package_label_principal_display_panel":["Principal display panel NDC 0904-6407-61 MAJOR ® compare to the active ingredient in Dulcolax® Laxative Tablets* bisacodyl USP bisacodyl USP, 5 mg stimulant laxative gentle, dependable constipation relief enteric coated 100 tablets (10 x 10) unit dose comfort coated tablets actual size *This product is not manufactured or distributed by A. Nattermann & Cie. GmbH, owner of the registered trademark Dulcolax® Laxative Tablets. TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 ORG042532712 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Major 44-327 Major 44-327"],"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":"4fb4e630-875f-4c82-86d9-7696857e3c42","spl_product_data_elements":["Bisacodyl Bisacodyl BISACODYL DEACETYLBISACODYL ACACIA CALCIUM CARBONATE CARNAUBA WAX SILICON DIOXIDE D&C YELLOW NO. 10 ALUMINUM LAKE FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE ANHYDROUS LACTOSE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE WATER SODIUM BENZOATE SODIUM BICARBONATE SODIUM LAURYL SULFATE 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 avoid excessive humidity use by expiration date on package store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)"],"version":"20","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"]}