{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"dosage_and_administration":["Directions • do not exceed recommended dose • adults and children 12 years and older: take 1-3 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor • children under 12: consult a doctor"],"effective_time":"20231016","id":"07cec8ef-ecca-ac49-e063-6294a90a6083","inactive_ingredient":["Inactive ingredients FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water."],"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":{"application_number":["M007"],"brand_name":["Docusate Sodium"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["Asclemed USA, Inc."],"original_packager_product_ndc":["57896-401"],"package_ndc":["76420-225-30","76420-225-60","76420-225-90"],"product_ndc":["76420-225"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["07cec8ef-ecca-ac49-e063-6294a90a6083"],"spl_set_id":["30fc8c07-c26b-4bcc-a727-6e193f5727fd"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Package Label 1"],"purpose":["Purpose Stool Softener Laxative"],"set_id":"30fc8c07-c26b-4bcc-a727-6e193f5727fd","spl_patient_package_insert":["Repackaged/Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501"],"spl_product_data_elements":["Docusate Sodium Docusate Sodium FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 SORBITOL WATER FD&C YELLOW NO. 6 MANNITOL DOCUSATE SODIUM DOCUSATE SCU1 reddish"],"storage_and_handling":["Other information • each softgel contains: sodium 7 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • Tamper Evident: Do not use if imprinted seal under cap is missing or broken."],"version":"2","warnings":["Warnings Ask a doctor before use if you • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. 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."]}