{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 250 mg"],"dosage_and_administration":["Directions adults and children 12 years and older: take 1 softgel daily or as directed by a doctor children under 12: do not use do not exceed recommended dose"],"effective_time":"20240404","how_supplied":["HOW SUPPLIED NDC: 71335-1677-1: 30 Capsules in a BOTTLE NDC: 71335-1677-2: 60 Capsules in a BOTTLE NDC: 71335-1677-3: 100 Capsules in a BOTTLE NDC: 71335-1677-4: 7 Capsules in a BOTTLE NDC: 71335-1677-5: 90 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504"],"id":"98bdddeb-53ee-4383-9a6f-d60d4082f450","inactive_ingredient":["Inactive ingredients FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerol, PEG, purified water, sorbitol special"],"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":["57896-426"],"package_ndc":["71335-1677-1","71335-1677-2","71335-1677-3","71335-1677-4","71335-1677-5"],"product_ndc":["71335-1677"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1245468"],"spl_id":["98bdddeb-53ee-4383-9a6f-d60d4082f450"],"spl_set_id":["1f11cf85-b094-4ca4-8b48-2d3a9093304b"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Docusate Sodium 250 mg Capsule Label"],"purpose":["Purpose Stool Softener"],"questions":["Questions or comments? 1-800-540-3765"],"set_id":"1f11cf85-b094-4ca4-8b48-2d3a9093304b","spl_product_data_elements":["Stool Softener DOCUSATE SODIUM GELATIN, UNSPECIFIED GLYCERIN FD&C YELLOW NO. 6 C.I. FOOD YELLOW 3 (FREE ACID) WATER FD&C RED NO. 40 POLYETHYLENE GLYCOL, UNSPECIFIED DOCUSATE SODIUM DOCUSATE SORBITOL oblong SCU1"],"storage_and_handling":["Other information each softgel contains: sodium 15 mg store at 59°-77°F (15°-25°C) keep tightly closed product of Romania Package not child resistant 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."]}