{
  "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": 4
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sennosides, Docusate Sodium Sennosides, Docusate Sodium MALTODEXTRIN CROSCARMELLOSE SODIUM STARCH, CORN SODIUM LAURYL SULFATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 STEARIC ACID DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSES DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES TITANIUM DIOXIDE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C RED NO. 40 ALUMINUM LAKE MICROCRYSTALLINE CELLULOSE SODIUM BENZOATE TALC LIGHT MINERAL OIL 49;0"
      ],
      "active_ingredient": [
        "Drug Facts Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg"
      ],
      "purpose": [
        "Purposes Stool softener Stimulant laxative"
      ],
      "indications_and_usage": [
        "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours"
      ],
      "warnings": [
        "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 two weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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."
      ],
      "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 two weeks"
      ],
      "stop_use": [
        "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs 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."
      ],
      "overdosage": [
        "In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "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 up to 1 tablet daily children under 2 years ask a doctor"
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\" width=\"100%\"><tbody><tr><td>adults and children 12 years and over</td><td>take 2-4 tablets daily</td></tr><tr><td>children 6 to under 12 years of age</td><td>take 1-2 tablets daily</td></tr><tr><td>children 2 to under 6 years of age</td><td>take up to 1 tablet daily</td></tr><tr><td>children under 2 years</td><td>ask a doctor</td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "each tablet contains: calcium 5 mg Store in a dry place at 15° – 30°C (59° – 86°F)."
      ],
      "inactive_ingredient": [
        "corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide."
      ],
      "questions": [
        "Questions or comments? 1-800-231-4670"
      ],
      "spl_unclassified_section": [
        "Keep this carton for complete product information Tamper Evident: Do not use if sealed blister units are broken or damaged. Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com"
      ],
      "package_label_principal_display_panel": [
        "Major NDC 0904-7440-61 Unit Dose Sennosides/Docusate Sodium 8.6mg/50mg Stool Softener/Stimulant Laxative 100 Tablets Major Label"
      ],
      "set_id": "1768b470-2808-fa46-e063-6394a90ac8d9",
      "id": "1768b470-2809-fa46-e063-6394a90ac8d9",
      "effective_time": "20240501",
      "version": "1",
      "openfda": {
        "application_number": [
          "M007"
        ],
        "brand_name": [
          "Sennosides, Docusate Sodium"
        ],
        "generic_name": [
          "SENNOSIDES, DOCUSATE SODIUM"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-7440"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOCUSATE SODIUM",
          "SENNOSIDES"
        ],
        "rxcui": [
          "998740"
        ],
        "spl_id": [
          "1768b470-2809-fa46-e063-6394a90ac8d9"
        ],
        "spl_set_id": [
          "1768b470-2808-fa46-e063-6394a90ac8d9"
        ],
        "package_ndc": [
          "0904-7440-61"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0309047440610"
        ],
        "unii": [
          "F05Q2T2JA0",
          "3FYP5M0IJX"
        ]
      }
    }
  ]
}