{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "spl_product_data_elements": [ "Stimulant Laxative Plus Stool Softener Docusate Sodium 50 mg and Sennosides 8.6 mg SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C RED NO. 40 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SODIUM BENZOATE TALC TITANIUM DIOXIDE ROUND TABLET PH32" ], "active_ingredient": [ "Active Ingredients (in each tablet) Docusate Sodium 50 mg Sennosides 8.6 mg" ], "purpose": [ "Purpose Stool softener Stimulant laxative" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally produces a bowel movement in 6 to 12 hours" ], "warnings": [ "Warnings Do not use laxative products for longer than 1 week unless told to do so by a doctor if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These could be sings 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 (1-800-222-1222)." ], "do_not_use": [ "Do not use laxative products for longer than 1 week unless told to do so by a doctor if you are presently taking mineral oil, unless told to do so by a doctor" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These could be sings of a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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 (1-800-222-1222)." ], "dosage_and_administration": [ "Directions take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses adults and children 12 years and over take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take upto 1 tablet daily children under 2 ask a doctor" ], "dosage_and_administration_table": [ "
adults and children 12 years and overtake 2-4 tablets daily
children 6 to under 12 years of agetake 1-2 tablets daily
children 2 to under 6 years of agetake upto 1 tablet daily
children under 2 ask a doctor
" ], "storage_and_handling": [ "Other information each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium store at 20-25°C (68-77°F); excursions permitted between 15-30 o C (59-86 o F). Keep tightly closed." ], "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide" ], "questions": [ "Questions or comments? (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)" ], "how_supplied": [ "HOW SUPPLIED Docusate Sodium 50 mg - Sennosides 8.6 mg NDC: 71335-2693-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-2: 120 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-3: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-4: 90 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-5: 100 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-6: 28 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-7: 56 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-8: 14 Tablets in a BOTTLE, PLASTIC NDC: 71335-2693-9: 20 Tablets in a BOTTLE, PLASTIC Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504" ], "package_label_principal_display_panel": [ "Docusate/ Sennosides 50/8.6 mg Tablet Label" ], "set_id": "12f613e4-c919-4cc4-a445-eb30039ae45f", "id": "1502a2b6-0ef3-40ca-820a-b9ff835cad03", "effective_time": "20250918", "version": "1", "openfda": { "application_number": [ "M007" ], "brand_name": [ "Stimulant Laxative Plus Stool Softener" ], "generic_name": [ "DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG" ], "manufacturer_name": [ "Bryant Ranch Prepack" ], "product_ndc": [ "71335-2693" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DOCUSATE SODIUM", "SENNOSIDES" ], "rxcui": [ "998740" ], "spl_id": [ "1502a2b6-0ef3-40ca-820a-b9ff835cad03" ], "spl_set_id": [ "12f613e4-c919-4cc4-a445-eb30039ae45f" ], "package_ndc": [ "71335-2693-1", "71335-2693-2", "71335-2693-3", "71335-2693-4", "71335-2693-5", "71335-2693-6", "71335-2693-7", "71335-2693-8", "71335-2693-9" ], "original_packager_product_ndc": [ "0536-1248" ], "unii": [ "F05Q2T2JA0", "3FYP5M0IJX" ] } } ] }