{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-05-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "BISACODYL BISCODYL ACACIA CALCIUM SULFATE ANHYDROUS CALCIUM CATION ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN STEARIC ACID BISACODYL DEACETYLBISACODYL FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID POVIDONE GELATIN FERROSOFERRIC OXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POLYVINYL ACETATE PHTHALATE SODIUM STARCH GLYCOLATE TYPE A CORN SUCROSE TALC TITANIUM DIOXIDE SHELLAC FERRIC OXIDE YELLOW D&C YELLOW NO. 10 TCL003" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredient (in each tablet) Bisacodyl USP, 5 mg" ], "purpose": [ "Purpose Stimulant Laxative" ], "indications_and_usage": [ "Uses for relief of occasional constipation and irregularity this product generally produces bowel movement in 6-12 hours" ], "warnings": [ "Warnings WARNINGS Warning: 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 two weeks. When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps. Do not use if you cannot swallow without chewing Ask a doctor before use if you have stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product it may cause stomach discomfort, faintness and cramps do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using this product. 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 (1-800-222-1222)." ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks" ], "ask_doctor_or_pharmacist": [ "When using this product it may cause stomach discomfort, faintness and cramps do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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 (1-800-222-1222)." ], "storage_and_handling": [ "Other information each tablet contains: magnesium 5 mg store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package protect from excessive humidity" ], "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years of age and over: 1 to 3 tablets in a single daily dose children 6 to under 12 years of age: 1 tablet in a single daily dose children under 6 years of age: ask a doctor" ], "inactive_ingredient": [ "Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide" ], "questions": [ "Questions or comments? Call 1-800-910-6874" ], "package_label_principal_display_panel": [ "bisacodyl-100s-label bisacodyl-25s-ifc" ], "set_id": "8ed281d5-b17e-e3bb-e053-2995a90a2590", "id": "1d46555d-827c-b154-e063-6294a90ad3d5", "effective_time": "20240715", "version": "4", "openfda": { "application_number": [ "M007" ], "brand_name": [ "BISACODYL" ], "generic_name": [ "BISCODYL" ], "manufacturer_name": [ "TARGET CORPORATION" ], "product_ndc": [ "11673-182" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BISACODYL" ], "rxcui": [ "308753" ], "spl_id": [ "1d46555d-827c-b154-e063-6294a90ad3d5" ], "spl_set_id": [ "8ed281d5-b17e-e3bb-e053-2995a90a2590" ], "package_ndc": [ "11673-182-52", "11673-182-01" ], "is_original_packager": [ true ], "upc": [ "0311673182017", "0349483003529" ], "nui": [ "N0000009371", "N0000175812", "N0000009871" ], "pharm_class_pe": [ "Increased Large Intestinal Motility [PE]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "pharm_class_epc": [ "Stimulant Laxative [EPC]" ], "unii": [ "10X0709Y6I" ] } } ] }