{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain, nausea or vomitting a sudden change in bowel habits that lasts more than 2 weeks"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are presently taking mineral oil"],"dosage_and_administration":["Directions take with a glass of water Adults and children 12 years and over 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. Children 2 to under 12 years of age 1 softgel daily children under 2 years of age ask a doctor"],"dosage_and_administration_table":["<table border=\"single\"><col width=\"25.3%\"/><col width=\"80.7%\"/><tbody><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\"><paragraph>Adults and children 12 years and over</paragraph></td><td align=\"left\" styleCode=\"Botrule Rrule\"><paragraph>1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\"><paragraph>Children 2 to under 12 years of age</paragraph></td><td align=\"left\" styleCode=\"Botrule Rrule\"><paragraph>1 softgel daily</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>children under 2 years of age</paragraph></td><td align=\"left\" styleCode=\"Botrule Rrule\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20241230","how_supplied":["HOW SUPPLIED Product: 50090-7479 NDC: 50090-7479-1 100 CAPSULE, LIQUID FILLED in a BOTTLE, PLASTIC NDC: 50090-7479-4 30 CAPSULE, LIQUID FILLED in a BOTTLE, PLASTIC"],"id":"ac138ca0-1d8c-4c98-be86-d16fb4d3f2e9","inactive_ingredient":["Inactive ingredients FD&C Red # 40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China"],"indications_and_usage":["Uses for temporary relief of occasional constipation and irregularity this product 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":{"application_number":["M007"],"brand_name":["DOCUSATE SODIUM"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["A-S Medication Solutions"],"original_packager_product_ndc":["53345-008"],"package_ndc":["50090-7479-4","50090-7479-1"],"product_ndc":["50090-7479"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["ac138ca0-1d8c-4c98-be86-d16fb4d3f2e9"],"spl_set_id":["946abcdb-96bd-43e6-992a-bb97679c00f0"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["DOCUSATE SODIUM Label Image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener"],"set_id":"946abcdb-96bd-43e6-992a-bb97679c00f0","spl_product_data_elements":["DOCUSATE SODIUM DOCUSATE SODIUM RED 40 KI5 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL AQUA SORBITOL ANHYDROUS CITRIC ACID DOCUSATE SODIUM DOCUSATE OVAL PC1"],"spl_unclassified_section":["Drug Facts"],"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"],"storage_and_handling":["Other information each softgel contains : sodium 5 mg store at room temperature 15°-30°C (59°-86°F) protect from excessive humidity"],"version":"1","warnings":["Warnings Ask a doctor before use if you have stomach pain, nausea or vomitting a sudden change in bowel habits that lasts more than 2 weeks Ask a doctor or pharmacist before use if you are presently taking mineral oil 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 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."]}