{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Dulcolax Laxative Bisacodyl BISACODYL DEACETYLBISACODYL FAT, HARD"
      ],
      "spl_unclassified_section": [
        "Dulcolax® Medicated Laxative Suppositories Drug Facts",
        "Other information store at 20°-25°C (68°-77°F)"
      ],
      "active_ingredient": [
        "Active i ngredient (in each suppository) Bisacodyl (USP) 10 mg"
      ],
      "purpose": [
        "Purpose Stimulant laxative"
      ],
      "indications_and_usage": [
        "Use for relief of occasional constipation and irregularity this product generally produces bowel movement in 15 minutes to 1 hour"
      ],
      "warnings": [
        "Warnings For rectal use only Ask a doctor before use if you have stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks"
      ],
      "when_using": [
        "When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps"
      ],
      "stop_use": [
        "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week"
      ],
      "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. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Peel open plastic. Insert suppository into rectum, pointed end first. Retain about 15 to 20 minutes. adults and children 12 years of age and over 1 suppository in a single daily dose. children 6 to under 12 years of age ½ suppository in a single daily dose children under 6 years of age ask a doctor"
      ],
      "dosage_and_administration_table": [
        "<table><col width=\"346\"/><col width=\"346\"/><tbody><tr><td styleCode=\"Toprule \">adults and children 12 years of age and over</td><td styleCode=\"Toprule \">1 suppository in a single daily dose.</td></tr><tr><td styleCode=\"Toprule \">children 6 to under 12 years of age </td><td styleCode=\"Toprule \">&#xBD; suppository in a single daily dose</td></tr><tr><td styleCode=\"Toprule \">children under 6 years of age</td><td styleCode=\"Toprule \">ask a doctor</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive ingredient hard fat"
      ],
      "questions": [
        "Question s ? Call 1- 866 - 844 - 2798 or visit www.Dulcolax.com Keep carton as it contains important product information."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Dulcolax Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative MEDICATED LAXATIVE SUPPOSITORY 4 COMFORT SHAPED SUPPOSITORIES DO NOT SWALLOW Dulcolax Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative MEDICATED LAXATIVE SUPPOSITORY 4 COMFORT SHAPED SUPPOSITORIES DO NOT SWALLOW"
      ],
      "set_id": "016a4920-77a7-4ac3-8d9d-fd2f564dfee6",
      "id": "d39ca8c0-d92a-4c16-a35e-efa8acc21aa5",
      "effective_time": "20240201",
      "version": "4",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Dulcolax Laxative"
        ],
        "generic_name": [
          "BISACODYL"
        ],
        "manufacturer_name": [
          "Chattem, Inc."
        ],
        "product_ndc": [
          "41167-0210"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "RECTAL"
        ],
        "substance_name": [
          "BISACODYL"
        ],
        "rxcui": [
          "198509",
          "209601"
        ],
        "spl_id": [
          "d39ca8c0-d92a-4c16-a35e-efa8acc21aa5"
        ],
        "spl_set_id": [
          "016a4920-77a7-4ac3-8d9d-fd2f564dfee6"
        ],
        "package_ndc": [
          "41167-0210-3",
          "41167-0210-5",
          "41167-0210-1",
          "41167-0210-2"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000009371",
          "N0000175812",
          "N0000009871"
        ],
        "pharm_class_pe": [
          "Increased Large Intestinal Motility [PE]",
          "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
        ],
        "pharm_class_epc": [
          "Stimulant Laxative [EPC]"
        ],
        "unii": [
          "10X0709Y6I"
        ]
      }
    }
  ]
}