{"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 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"],"dosage_and_administration_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"47%\"/><col width=\"37%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years of age and over </paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>1 to 3 tablets in a single daily dose </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 6 to under 12 years of age</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>1 tablet in a single daily dose</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>children under 6 years of age</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20260908","id":"90722fad-52fc-4422-b913-92a97eebb505","inactive_ingredient":["Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow No. 10, FD&C yellow No. 6, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide."],"indications_and_usage":["Use ▪ for relief of occasional constipation and irregularity ▪ this product generally produces a 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 at (1-800-222-1222)."],"openfda":{"application_number":["M007"],"brand_name":["Bisacodyl Stimulant Laxative"],"generic_name":["BISACODYL"],"is_original_packager":[true],"manufacturer_name":["Raritan Pharmaceuticals Inc"],"nui":["N0000009371","N0000175812","N0000009871"],"package_ndc":["68163-116-25"],"pharm_class_epc":["Stimulant Laxative [EPC]"],"pharm_class_pe":["Increased Large Intestinal Motility [PE]","Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["68163-116"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308753"],"spl_id":["90722fad-52fc-4422-b913-92a97eebb505"],"spl_set_id":["b99c1a6d-3034-4822-8540-210179c06857"],"substance_name":["BISACODYL"],"unii":["10X0709Y6I"]},"package_label_principal_display_panel":["Principal Display Panel NDC# 68163-116-25 *Compare to the Active Ingredient in Dulcolax® Tablets Bisacodyl Laxative Bisacodyl, USP 5 mg/Stimulant Laxative Gentle, Overnight relief constipation relief 25 Coated Tablets *This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Dulcolax® Tablets. TAMPER EVIDENT: Do not use if any individual unit is broken or open. IMPORTANT: Keep this carton for future reference on full labeling. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 DRx Choice Bisacodyl Laxative"],"package_label_principal_display_panel_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">IMPORTANT:</content> Keep this carton for future reference on full labeling.</paragraph></td></tr></tbody></table>"],"pregnancy_or_breast_feeding":["If pregnancy or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stimulant laxative"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"b99c1a6d-3034-4822-8540-210179c06857","spl_product_data_elements":["Bisacodyl Stimulant Laxative Bisacodyl BISACODYL DEACETYLBISACODYL ACACIA CALCIUM SULFATE ANHYDROUS ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 Polyvinyl Acetate Phthalate POVIDONE, UNSPECIFIED SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID RAW SUGAR TALC TITANIUM DIOXIDE RP116"],"spl_unclassified_section":["Other information • store at room temperature • Protect from excessive humidity"],"stop_use":["Stop use and ask a doctor if ▪ you have rectal bleeding or fail to have bowl movement after using this product. These could be signs of a serious condition. ▪ you need to use a laxative for more than 1 week"],"version":"8","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 ▪ 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 bowl 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 pregnancy 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 at (1-800-222-1222)."],"when_using":["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"]}