{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"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 of age and over take 1 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"63%\"/><col width=\"37%\"/><tbody><tr><td styleCode=\"Rrule 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 softgels daily</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children 2 to under 12 years of age</paragraph></td><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>take 1 softgel daily</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children under 2 years of age </paragraph></td><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20260625","id":"5516c65f-7c50-a154-e063-6394a90a0181","inactive_ingredient":["Inactive ingredients FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl. Distributed by: American Health Packaging 2550 John Glenn Avenue, Suite A Columbus, OH 43217 712901 0412901/0216PS"],"indications_and_usage":["Uses for relief of occasional constipation (irregularity) generally produces a bowel movement within 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":{"application_number":["M007"],"brand_name":["Docusate Sodium"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["American Health Packaging"],"package_ndc":["60687-129-11","60687-129-01"],"product_ndc":["60687-129"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["5516c65f-7c50-a154-e063-6394a90a0181"],"spl_set_id":["be7cab51-ce7e-465d-95db-083e69288cfd"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Principal Display Panel – Carton – 100 mg NDC 60687- 129 -01 DOCUSATE SODIUM, USP Stool Softener Laxative 100 mg 100 Softgels (10 x 10) Distributed by: American Health Packaging, Columbus, Ohio 43217 712901 0412901/1025 100 mg Docusate Sodium Softgels Carton","Principal Display Panel - Blister – 100 mg DOCUSATE SODIUM, USP Stool Softener Laxative Softgel 100 mg 100 mg Docusate Sodium Softgel Blister"],"purpose":["Purpose Stool softener laxative"],"set_id":"be7cab51-ce7e-465d-95db-083e69288cfd","spl_product_data_elements":["Docusate Sodium Docusate Sodium FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 WATER SORBITOL DOCUSATE SODIUM DOCUSATE Reddish SCU1"],"spl_unclassified_section":["Other information Each softgel contains: sodium 7 mg VERY LOW SODIUM Store at room temperature between 15° to 30°C (59° to 86°F) FOR YOUR PROTECTION: Do not use if blister is torn or broken."],"version":"9","warnings":["Warnings Do not use if you are currently taking mineral oil, unless directed by a doctor when abdominal pain, nausea or vomiting are present unless directed by a doctor for longer than one week unless directed by a doctor Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks. Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition. If pregnant or breast-feeding, ask a health care professional before use."]}