{
  "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": {
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      "total": 27
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  "results": [
    {
      "spl_product_data_elements": [
        "Senna S DOCUSATE SODIUM, SENNOSIDES POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL POVIDONE FD&C YELLOW NO. 6 FD&C RED NO. 40 SILICON DIOXIDE GELATIN GLYCERIN SORBITOL SORBITAN WATER SYNTHETIC BEESWAX TITANIUM DIOXIDE DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES SDC"
      ],
      "active_ingredient": [
        "Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg"
      ],
      "purpose": [
        "Purpose Stool softener Laxative"
      ],
      "indications_and_usage": [
        "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6-12 hours"
      ],
      "warnings": [
        "Warnings Do not use if you are now taking mineral oil, unless directed by a doctor laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a periodof 2 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 may indicate 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 (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use if you are now taking mineral oil, unless directed by a doctor laxative products for longer than 1 week unless directed 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 continues over a periodof 2 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 may indicate 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 (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age or older 2 softgels once a day 4 softgels twice a day children 6 to under 12 years 1 softgel once a day 2 softgels twice a day children under 6 years of age ask a doctor ask a doctor"
      ],
      "dosage_and_administration_table": [
        "<table><col width=\"1px\"/><col width=\"1px\"/><col width=\"1px\"/><tbody><tr><td align=\"center\" styleCode=\"Botrule Rrule Toprule\"> age</td><td align=\"center\" styleCode=\"Botrule Rrule Toprule\">starting dosage </td><td align=\"center\" styleCode=\"Botrule Toprule\">maximum dosage </td></tr><tr><td styleCode=\"Botrule Rrule\">adults and children 12 years of age or older</td><td styleCode=\"Botrule Rrule\">2 softgels once a day</td><td>4 softgels twice a day </td></tr><tr><td styleCode=\"Botrule Rrule\">children 6 to under 12 years</td><td styleCode=\"Botrule Rrule\">1 softgel once a day</td><td styleCode=\"Botrule\">2 softgels twice a day </td></tr><tr><td styleCode=\"Botrule Rrule\">children under 6 years of age</td><td styleCode=\"Botrule Rrule\">ask a doctor </td><td styleCode=\"Botrule\">ask a doctor </td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information each softgel contains : calcium 3 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Colloidal Silicon Dioxide, FD&C Red 40, FD&C yellow No. 6, Gelatin, Glycerin, Polyethylene Glycol -400, Propylene Glycol, Povidone (PVPK-30), Purified Water, Sorbitol Sorbitan Solution, Titanium Dioxide, yellow bees wax"
      ],
      "questions": [
        "Questions or comments? Call 1-800-373-6981 Monday-Friday 9AM-5PM EST"
      ],
      "spl_unclassified_section": [
        "Distributed by: Shield Pharmaceuticals LLC Ronkonkoma, NY 11779"
      ],
      "package_label_principal_display_panel": [
        "Senna-S Docusate Sodium 50 mg and Sennosides 8.6 mg Label Label-Front Label-Back"
      ],
      "set_id": "0be906d8-3db5-4218-bbdf-f1d126007990",
      "id": "453ba1cd-773e-2e7f-e063-6394a90a8251",
      "effective_time": "20251205",
      "version": "2",
      "openfda": {
        "application_number": [
          "M007"
        ],
        "brand_name": [
          "Senna S"
        ],
        "generic_name": [
          "DOCUSATE SODIUM, SENNOSIDES"
        ],
        "manufacturer_name": [
          "Shield Pharmaceuticals Corp"
        ],
        "product_ndc": [
          "83059-0120"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOCUSATE SODIUM",
          "SENNOSIDES"
        ],
        "rxcui": [
          "1791612"
        ],
        "spl_id": [
          "453ba1cd-773e-2e7f-e063-6394a90a8251"
        ],
        "spl_set_id": [
          "0be906d8-3db5-4218-bbdf-f1d126007990"
        ],
        "package_ndc": [
          "83059-0120-6"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F05Q2T2JA0",
          "3FYP5M0IJX"
        ]
      }
    }
  ]
}