{"active_ingredient":["Active Ingredient (in each softgel) Docusate Sodium 250 mg"],"ask_doctor_or_pharmacist":["Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of two weeks."],"dosage_and_administration":["Directions Adults and Children over 12 years of age Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. Children under 12 years of age Do not use this product for children under 12 years of age, unless directed by a doctor."],"dosage_and_administration_table":["
Adults and Children over 12 years of ageTake orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children under 12 years of ageDo not use this product for children under 12 years of age, unless directed by a doctor.
"],"effective_time":"20250205","id":"2d687989-bace-67e9-e063-6394a90a0221","inactive_ingredient":["Inactive Ingredients FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol."],"indications_and_usage":["Uses For the relief of occasional constipation. Helps to prevent dry, hard stools. This product generally produces a bowel movement within 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 (800) 222-1222."],"openfda":{"application_number":["M007"],"brand_name":["Docusate Sodium"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["PD-Rx Pharmaceuticals, Inc."],"original_packager_product_ndc":["54629-601"],"package_ndc":["72789-166-60"],"product_ndc":["72789-166"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1245468"],"spl_id":["2d687989-bace-67e9-e063-6394a90a0221"],"spl_set_id":["6a7e4193-22d2-491e-9842-5c43f571fc65"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel Docusate Sodium, USP Stool Softener 250 mg Each 72789166 Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a healthcare professional before use."],"purpose":["Purpose Stool Softener"],"questions":["Questions Call 1 (800) 682-9862"],"set_id":"6a7e4193-22d2-491e-9842-5c43f571fc65","spl_product_data_elements":["Docusate Sodium Docusate Sodium FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 1000 PROPYLENE GLYCOL WATER SORBITOL DOCUSATE SODIUM DOCUSATE NV12"],"spl_unclassified_section":["Other Information Each softgel contains 13 mg of Sodium. Store at room temperature between 15°C to 30°C (59°F to 86°F). Do not use if printed seal under cap is broken or missing. For identification purposes, each softgel will have an imprint that reads NV12."],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use."],"version":"6","warnings":["WARNINGS Do not use: If you are currently taking mineral oil, unless directed by a doctor. When abdominal pain, nausea, or vomiting are present. For longer than one week unless directed by a doctor. Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of two weeks. Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222."]}