{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"dosage_and_administration":["Directions • adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor • children under 12: consult a doctor • do not exceed recommended dose"],"effective_time":"20220303","how_supplied":["HOW SUPPLIED NDC: 71335-1593-1: 30 Tablets in a BOTTLE NDC: 71335-1593-2: 100 Tablets in a BOTTLE NDC: 71335-1593-3: 60 Tablets in a BOTTLE NDC: 71335-1593-4: 120 Tablets in a BOTTLE NDC: 71335-1593-5: 90 Tablets in a BOTTLE NDC: 71335-1593-6: 180 Tablets in a BOTTLE NDC: 71335-1593-7: 10 Tablets in a BOTTLE NDC: 71335-1593-8: 28 Tablets in a BOTTLE NDC: 71335-1593-9: 56 Tablets in a BOTTLE NDC: 71335-1593-0: 18 Tablets in a BOTTLE"],"id":"42cdd7da-1036-4be3-819a-3ce01a1cad91","inactive_ingredient":["Inactive ingredients FD&C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol sorbitan solution, water. Also contains D&C yellow #10 or FD&C yellow #6 (sunset yellow)."],"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":["Docusate Sodium 100mg Capsule Label"],"purpose":["Purpose Stool Softener Laxative"],"set_id":"69c37a14-88da-4e5c-8543-dd1cdabf5f8b","spl_product_data_elements":["Stool Softener Docusate Sodium D&C YELLOW NO. 10 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL WATER FD&C YELLOW NO. 6 SORBITAN DOCUSATE SODIUM DOCUSATE 401"],"storage_and_handling":["Other information • each softgel contains: sodium 5 mg. very low sodium • store at 15°C-25°C(59° F-77° F) • keep tightly closed • Tamper Evident: Do not use if imprinted seal under cap is missing or broken."],"version":"3","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."]}