{"active_ingredient":["Active ingredient (in each capsule) Docusate sodium 100 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 1-3 capsules daily children 2 to under 12 years of age take 1 capsule daily children under 2 years ask a doctor"],"dosage_and_administration_table":["<table width=\"65%\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr styleCode=\"Botrule\"> <td>adults and children 12 years and over</td> <td styleCode=\"Lrule\">take 1-3 capsules daily</td> </tr> <tr styleCode=\"Botrule\"> <td>children 2 to under 12 years of age</td> <td styleCode=\"Lrule\">take 1 capsule daily</td> </tr> <tr> <td>children under 2 years</td> <td styleCode=\"Lrule\">ask a doctor</td> </tr> </tbody> </table>"],"effective_time":"20100209","id":"09ea20a4-6502-4c60-bca9-86b493b5b1e3","inactive_ingredient":["Inactive ingredients D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, PEG 400, propylene glycol, propylparaben, sorbitol, titanium dioxide"],"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 Docusate Sodium capsules USP 100mg Each Softgel Contains: (Docusate Sodium USP 100mg) LOT NO : QUANTITY : DRUM NO : NDC NO : 68210-0401-* MFG DATE : EXP DATE : WARNING: KEEP OUT OF REACH OF CHILDREN STORE CONTROLLED ROOM TEMPERATURE OF 59° – 86°F (15° – 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE F.D & C.ACT AND REGULATIONS THEREUNDER. MANUFACTURED BY: SOFTGEL HEALTHCARE PVT LIMITED INDIA LABELLER CODE : 35916 LIC NO. : TN/DRUGS/00002124 MANUFACTURED FOR: SPIRIT PHARMACEUTICALS LLC 225 LINCOLN HWY, STE 205 FAIRLESS HILLS, PA 19030 PH.# 215 943 4000 FAX.# 215 943 4039 CAUTION : \"FOR MANUFACTURING, PROCESSING OR REPACKING\" 1 - 10 2 - 30 3 - 100 4 - 1000 5 - 16000 6 - 20000 Principal Display Panel"],"package_label_principal_display_panel_table":["<table width=\"75%\"> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"25%\" align=\"left\" valign=\"top\"/> <tbody> <tr styleCode=\"Toprule\"> <td>LOT NO</td> <td>:</td> <td/> <td/> <td>QUANTITY</td> <td>:</td> </tr> <tr> <td>DRUM NO</td> <td>:</td> <td/> <td/> <td>NDC NO</td> <td>: 68210-0401-*</td> </tr> <tr styleCode=\"Botrule\"> <td>MFG DATE</td> <td>:</td> <td/> <td/> <td>EXP DATE</td> <td>:</td> </tr> </tbody> </table>"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"set_id":"84ee7230-0bf6-4107-b5fa-d6fa265139d0","spl_product_data_elements":["DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE POLYETHYLENE GLYCOL 400 GLYCERIN GELATIN SORBITOL WATER D&C RED No. 33 FD&C RED No. 40 FD&C Yellow No. 6 DO4"],"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 laxative for more than 1 week"],"version":"1","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 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."]}