{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 50 mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks"],"do_not_use":["Do not use if you are presently taking mineral oil, unless told to do so by a doctor"],"dosage_and_administration":["Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. Adults and children 12 years and over take 1 to 6 softgels daily Children 2 to under 12 years of age take 1 to 3 softgels daily children under 2 years ask a doctor"],"dosage_and_administration_table":["<table width=\"468\" border=\"1\"> <colgroup> <col width=\"25.3%\"/> <col width=\"80.7%\"/> </colgroup> <tbody> <tr> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\"> <paragraph>Adults and children 12 years and over</paragraph> </td> <td styleCode=\"Botrule Rrule\" align=\"left\"> <paragraph>take 1 to 6 softgels daily</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\"> <paragraph>Children 2 to under 12 years of age</paragraph> </td> <td styleCode=\"Botrule Rrule\" align=\"left\"> <paragraph>take 1 to 3 softgels daily</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule Lrule Rrule\" align=\"left\"> <paragraph>children under 2 years</paragraph> </td> <td styleCode=\"Botrule Rrule\" align=\"left\"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20191210","id":"d5285de6-d5e0-4571-a0e8-4864c5396984","inactive_ingredient":["Inactive ingredients citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China"],"indications_and_usage":["Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30ct STOOL SOFTENERNDC 51013-111-20 Compare to the active ingredient in Colace® 50 mg 50 MG DOCUSATE SODIUM PER SOFTGEL 30 Softgels Carton Label Bottle Label","PRINCIPAL DISPLAY PANEL - 100ct STOOL SOFTENER NDC 51013-111-24 Compare to the active ingredient in Colace® 50 mg 50 MG DOCUSATE SODIUM PER SOFTGEL 100 Softgels Carton Label Bottle Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"set_id":"efdd022f-7971-4875-a6a8-fa3d1dce9c9c","spl_product_data_elements":["STOOL SOFTENER DOCUSATE SODIUM 50 MG DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 D&C RED NO. 33 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL ANHYDROUS CITRIC ACID clear OVAL PC20"],"spl_unclassified_section":["Drug Facts"],"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 stool softener laxative for more than 1 week"],"storage_and_handling":["Other information each softgel contains: sodium 3 mg VERY LOW SODIUM store at 15°-30°C (59°-86°F) Keep tightly closed."],"version":"3","warnings":["Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks 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 stool softener 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."]}