{"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":"20240705","how_supplied":["HOW SUPPLIED Docusate Sodium 100mg Capsule NDC: 71335-0294-1: 30 Tablets in a BOTTLE NDC: 71335-0294-2: 100 Tablets in a BOTTLE NDC: 71335-0294-3: 60 Tablets in a BOTTLE NDC: 71335-0294-4: 120 Tablets in a BOTTLE NDC: 71335-0294-5: 90 Tablets in a BOTTLE NDC: 71335-0294-6: 180 Tablets in a BOTTLE NDC: 71335-0294-7: 10 Tablets in a BOTTLE NDC: 71335-0294-8: 28 Tablets in a BOTTLE NDC: 71335-0294-9: 56 Tablets in a BOTTLE NDC: 71335-0294-0: 18 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504"],"id":"982de9ab-1968-4284-9dd9-1d05bf048fde","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":["Stool Softener"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["Bryant Ranch Prepack"],"original_packager_product_ndc":["57896-401"],"package_ndc":["71335-0294-1","71335-0294-2","71335-0294-3","71335-0294-4","71335-0294-5","71335-0294-6","71335-0294-7","71335-0294-8","71335-0294-9","71335-0294-0"],"product_ndc":["71335-0294"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["982de9ab-1968-4284-9dd9-1d05bf048fde"],"spl_set_id":["2c9a1fe7-b77b-436b-8701-9f95f642d001"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Docusate Sodium 100mg Capsule Label"],"purpose":["Purpose Stool Softener Laxative"],"set_id":"2c9a1fe7-b77b-436b-8701-9f95f642d001","spl_product_data_elements":["Stool Softener Docusate Sodium FD&C RED NO. 40 GELATIN, UNSPECIFIED 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":"8","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."]}