{"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 take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"10%\"/><col width=\"8%\"/><tbody><tr><td styleCode=\"Botrule Toprule \" valign=\"top\"><paragraph> adults and children 12 years of age and over </paragraph></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph> take 1 to 3 tablets in a single daily dose </paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph> children 6 to under 12 years of age</paragraph></td><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph> take 1 tablet in a single daily dose</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph> children under 6 years of age</paragraph></td><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph> ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20251203","id":"4509686d-0434-6464-e063-6294a90a4134","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, 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 temporary 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. (1-800-222-1222)."],"openfda":{"application_number":["M007"],"brand_name":["Gentle Laxative Stimulant Laxative"],"generic_name":["BISACODYL"],"is_original_packager":[true],"manufacturer_name":["QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)"],"nui":["N0000009371","N0000175812","N0000009871"],"package_ndc":["63868-908-25"],"pharm_class_epc":["Stimulant Laxative [EPC]"],"pharm_class_pe":["Increased Large Intestinal Motility [PE]","Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["63868-908"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308753"],"spl_id":["4509686d-0434-6464-e063-6294a90a4134"],"spl_set_id":["bcd3c07d-bd83-4452-9736-35c85db30c15"],"substance_name":["BISACODYL"],"unii":["10X0709Y6I"]},"package_label_principal_display_panel":["Principal Display Panel NDC# 63868-908-25 *Compare to the Active Ingredient in Dulcolax® Gentle Laxative Relieves Constipation & Irregularity Bisacodyl, USP 5 mg Relieves Constipation And Irregularity Overnight Comfort-Coated Tablets For Gentle, Predictable Constipation Relief 25 TABLETS 100% QC SATISFACTION GURANTEED *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., the owner of the registered trademark Dulcolax®. TAMPER EVIDENT: DO NOT USE IF any individual unit is broken or open. Distributed by C.D.M.A., Inc. 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300","Product Label QC(CDMA) Gentle Laxative Bisacodyl USP 5mg"],"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":"bcd3c07d-bd83-4452-9736-35c85db30c15","spl_product_data_elements":["Gentle Laxative Stimulant Laxative Bisacodyl 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 SUCROSE TALC TITANIUM DIOXIDE BISACODYL DEACETYLBISACODYL RP116"],"spl_unclassified_section":["Other information store at 20-25ºC (68º-77ºF) Protect from excessive humidity"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or no 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"],"version":"6","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 no 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 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. (1-800-222-1222)."],"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"]}