{"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":["
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
"],"effective_time":"20260414","id":"8fb9a72f-b4db-489c-b097-5fd82a39e728","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"],"manufacturer_name":["Cardinal Health 107, LLC"],"nui":["N0000009371","N0000175812","N0000009871"],"original_packager_product_ndc":["0904-6407"],"package_ndc":["55154-6897-0"],"pharm_class_epc":["Stimulant Laxative [EPC]"],"pharm_class_pe":["Increased Large Intestinal Motility [PE]","Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["55154-6897"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308753"],"spl_id":["8fb9a72f-b4db-489c-b097-5fd82a39e728"],"spl_set_id":["49cb9a34-4c76-48c5-92c0-39e0ffc805c3"],"substance_name":["BISACODYL"],"unii":["10X0709Y6I"],"upc":["0055154689700"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55154-6897-0 BISACODYL USP 5 mg Enteric Coated Tablets 10 TABLETS 5mg bag 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":"49cb9a34-4c76-48c5-92c0-39e0ffc805c3","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, UNSPECIFIED SODIUM BENZOATE SODIUM BICARBONATE SODIUM LAURYL SULFATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 5"],"spl_unclassified_section":[". *This product is not manufactured or distributed by A. Nattermann & Cie. GmbH, owner of the registered trademark Dulcolax® Laxative Tablets. 50844 ORG042532712 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Overbagged with 10 enteric coated tablets per bag, NDC 55154-6897-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L5071915-10325 / L5071915-20325 Rev. 10/25 M-17 Re-order No. 301829"],"spl_unclassified_section_table":["
Rev. 10/25
M-17
Re-order No. 301829
"],"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":"16","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"]}