{"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 and 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 and 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":"20241125","id":"27c7bf94-6590-15d9-e063-6394a90a5776","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) Co., 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 100mg"],"generic_name":["DOCUSATE SODIUM"],"is_original_packager":[true],"manufacturer_name":["Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd."],"package_ndc":["53345-029-01","53345-029-02"],"product_ndc":["53345-029"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["27c7bf94-6590-15d9-e063-6394a90a5776"],"spl_set_id":["c5bdfbfc-d24a-4088-9b60-ecea8120ff43"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label DOCUSATE SODIUM CAPSULES, 100 mg Quantity : 20000 Capsules NDC. No : 53345-029-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment, intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. Store at 15-30°C (59-86°F) CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING Shipping Label for 20000ct","PRINCIPAL DISPLAY PANEL - Shipping Label DOCUSATE SODIUM CAPSULES, 100 mg Quantity : 15000 Capsules NDC. No : 53345-029-02 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment, intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. Store at 15-30°C (59-86°F) CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING Shipping Label for 15000ct"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Stool softener laxative"],"set_id":"c5bdfbfc-d24a-4088-9b60-ecea8120ff43","spl_product_data_elements":["DOCUSATE SODIUM 100mg DOCUSATE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL ANHYDROUS CITRIC ACID DOCUSATE SODIUM DOCUSATE OVAL 655"],"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":"5","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."]}