{"active_ingredient":["Active ingredient(s) Bisacodyl 5mg"],"ask_doctor":["Ask a doctor before use if -you have a sudden change in bowel habits that lasts more than 2 weeks -stomach pain, nausea or vomiting"],"ask_doctor_or_pharmacist":[""],"do_not_use":["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 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"],"effective_time":"20191223","id":"df0a770a-eddd-4adc-96db-02da3cf01657","inactive_ingredient":["Inactive ingredients acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide."],"indications_and_usage":["Use(s) -relieves 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5mg NDC 67544-655 - Bisacodyl 5mg Bottle Label 5mg"],"pregnancy_or_breast_feeding":["Pregnancy/Breastfeeding ask a health professions before use."],"purpose":["Purpose Stimulant laxative"],"questions":["Questions To Report Adverse Drug Event call: (800) 616-2471"],"set_id":"458f701f-6f74-46c7-a801-6669cbf1b5b5","spl_product_data_elements":["Bisacodyl Enteric Coated 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 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE AMMONIUM NONOXYNOL-4 SULFATE SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE Polyvinyl Acetate Phthalate 5"],"spl_unclassified_section":["Other information Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations.","Repackaging Information Please reference the Product Characteristics section listed below for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 4mg 04 67544-655-04 06 67544-655-06 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20130612AW Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["<table border=\"0\" cellpadding=\"1\" cellspacing=\"1\"> <colgroup> <col width=\"100%\"/> </colgroup> <tbody> <tr styleCode=\"Toprule\"> <td valign=\"bottom\" align=\"left\"> <paragraph>Repackaged by Aphena Pharma Solutions - TN. See <content styleCode=\"bold italics\"> <linkHtml href=\"#Repack\">Repackaging Information</linkHtml> </content> for available configurations.</paragraph> </td> </tr> <tr> <td valign=\"bottom\" align=\"left\"> <renderMultiMedia referencedObject=\"mmAphena\"/> </td> </tr> </tbody> </table>","<table border=\"0\" cellpadding=\"1\" cellspacing=\"1\" width=\"28%\"> <colgroup> <col width=\"10%\"/> <col width=\"18%\"/> </colgroup> <tbody> <tr styleCode=\"Toprule\"> <td valign=\"bottom\" align=\"center\" styleCode=\"bold\">Count</td> <td valign=\"bottom\" align=\"center\"> <content styleCode=\"bold\">4mg</content> </td> </tr> <tr> <td valign=\"bottom\" align=\"center\">04</td> <td align=\"center\">67544-655-04</td> </tr> <tr> <td valign=\"bottom\" align=\"center\">06</td> <td align=\"center\">67544-655-06</td> </tr> </tbody> </table>"],"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":["Storage -store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F) -use by expiration date on package -protect from excessive humidity"],"version":"2","warnings":["Warnings Do not use Do not use if you cannot swallow without chewing Ask a doctor before use if -you have a sudden change in bowel habits that lasts more than 2 weeks -stomach pain, nausea or vomiting When using this product -do not use within 1 hour after taking an antacid or milk -do not chew or crush tablet(s) -you may have stomach discomfort, faintness or 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 Pregnancy/Breastfeeding ask a health professions 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."],"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) -you may have stomach discomfort, faintness or cramps"]}