{
  "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": "2026-05-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Bisacodyl Bisacodyl Suppositories PALM KERNEL OIL BISACODYL DEACETYLBISACODYL"
      ],
      "active_ingredient": [
        "Active ingredient (in each suppository) Purpose Bisacodyl USP 10 mg.............................................................Stimulant Laxative"
      ],
      "dosage_and_administration": [
        "Uses - relieves occasional constipation - this product generally produces a bowel movement in 15 minutes 1 hour"
      ],
      "warnings": [
        "Warning for rectal use only Do not use when abdominal pain, nausea, or vomiting are present."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have a sudden change in bowel habits that lasts over a period od 2 weeks."
      ],
      "when_using": [
        "When using this product you may experience - rectal burning - mild cramps - abdominal discomfort - faintness"
      ],
      "stop_use": [
        "Stop use and ask a doctor if - you have rectal bleeding or you fail to have a bowel movement after using a laxative. These may be signs of a serious condition. - you need to use a laxative for more than one week"
      ],
      "pregnancy": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "spl_medguide": [
        "If swallowed, get medical help or contact a Poison Control Center right away. You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088."
      ],
      "indications_and_usage": [
        "Directions - tear off one suppository from the strip - peel apart the wrapper - continue peeling apart to almost the full length of the suppository - gently remove the suppository from the wrapper - lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out - retain it for 15 to 20 minutes - Do not exceed recommended dose - if suppository seems soft, place in refrigerator for a short time before use. Adults and children 12 years and over 1 suppository once daily Children 6 to under 12 years 1/2 suppository once daily Children under 6 years Ask a doctor"
      ],
      "indications_and_usage_table": [
        "<table width=\"100%\"><caption/><tbody><tr><td> Adults and children 12 years and over</td><td> 1 suppository once daily</td></tr><tr><td> Children 6 to under 12 years</td><td> 1/2 suppository once daily</td></tr><tr><td> Children under 6 years </td><td> Ask a doctor</td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other information store at temperatures below 25 o C (77 o F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredient hydrogenated vegetable oil"
      ],
      "purpose": [
        "TAMPER EVIDENT: SUPPOSITORIES ARE WRAPPED IN TAMPER EVIDENT SEALED WRAPPERS. DO NOT USE IF WRAPPER IS TORN OR OPEN WHEN PURCHASED."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Oncor Pharmaceuticals NDC 83720-550-25 12 Suppositories 10 mg each Bisacodyl Suppositories Fast Acting Smulant Laxative Manufactured In USA For : Oncor Pharmaceuticals 6755 Business Pkwy Suite 202 Elkridge, MD 21075 United States. Rev. 12/24 Bisacodyl Suppositories"
      ],
      "set_id": "6f0aefc9-cd5f-4bdd-89c2-b6a80558987c",
      "id": "2c74d37c-18ff-b903-e063-6294a90a51dc",
      "effective_time": "20250124",
      "version": "1",
      "openfda": {
        "application_number": [
          "M007"
        ],
        "brand_name": [
          "Bisacodyl"
        ],
        "generic_name": [
          "BISACODYL SUPPOSITORIES"
        ],
        "manufacturer_name": [
          "Oncor Pharmaceuticals"
        ],
        "product_ndc": [
          "83720-550"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "RECTAL"
        ],
        "substance_name": [
          "BISACODYL"
        ],
        "rxcui": [
          "198509"
        ],
        "spl_id": [
          "2c74d37c-18ff-b903-e063-6294a90a51dc"
        ],
        "spl_set_id": [
          "6f0aefc9-cd5f-4bdd-89c2-b6a80558987c"
        ],
        "package_ndc": [
          "83720-550-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0383720550254"
        ],
        "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"
        ]
      }
    }
  ]
}