{"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 overtake 1 to 3 tablets in a single daily dose
children 6 to under 12 yearstake 1 tablet in a single daily dose
children under 6 yearsask a doctor
"],"effective_time":"20260427","id":"56e2e24b-debc-43ca-b385-745360a7ae41","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":["Gentle Laxative"],"generic_name":["BISACODYL"],"is_original_packager":[true],"manufacturer_name":["Topco Associates, LLC"],"nui":["N0000009371","N0000175812","N0000009871"],"package_ndc":["36800-327-03","36800-327-56"],"pharm_class_epc":["Stimulant Laxative [EPC]"],"pharm_class_pe":["Increased Large Intestinal Motility [PE]","Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["36800-327"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308753"],"spl_id":["56e2e24b-debc-43ca-b385-745360a7ae41"],"spl_set_id":["e4ff1277-b859-4c34-872f-0dc5b7879121"],"substance_name":["BISACODYL"],"unii":["10X0709Y6I"],"upc":["0036800461154"]},"package_label_principal_display_panel":["Principal Display Panel +TopCare® health NDC 36800-327-03 COMPARE TO DULCOLAX® LAXATIVE TABLETS ACTIVE INGREDIENT* Gentle Laxative BISACODYL USP 5 mg • STIMULANT LAXATIVE Gentle, Dependable Constipation Relief 10 COMFORT COATED TABLETS actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO LNKA0925 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com QUALITY GUARANTEED *This product is not manufactured or distributed by A. Nattermann & Cie. GmbH, owner of the registered trademark Dulcolax® Laxative Tablets. 50844 ORG042532703 TopCare 44-327A TopCare 44-327A"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stimulant laxative"],"questions":["Questions or comments? 1-888-423-0139"],"set_id":"e4ff1277-b859-4c34-872f-0dc5b7879121","spl_product_data_elements":["Gentle Laxative 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 need to use a laxative for more than 1 week you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition."],"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) see end flap for expiration date and lot number avoid excessive humidity"],"version":"11","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 use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) it may cause stomach discomfort, faintness, and cramps Stop use and ask a doctor if you need to use a laxative for more than 1 week you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. 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 use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) it may cause stomach discomfort, faintness, and cramps"]}