{
  "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": 19
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Gentle Laxative Bisacodyl Gentle Laxative Bisacodyl BISACODYL DEACETYLBISACODYL PALM KERNEL OIL"
      ],
      "active_ingredient": [
        "Drug Facts : Active ingredient (in each suppository) Bisacodyl 10 mg"
      ],
      "purpose": [
        "Drug facts Purpose Bisacodyl 10 mg ................................. Stimulant Laxative"
      ],
      "indications_and_usage": [
        "Uses ■ for relief of occasional constipation ■ this product generally produces bowel movement in 15 to 60 minutes"
      ],
      "warnings": [
        "Warnings ■ For rectal use only"
      ],
      "do_not_use": [
        "Do not use ■ when abdominal pain, nausea or vomiting are present ■ for a period longer than 1 week"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over a period of 2 weeks"
      ],
      "when_using": [
        "When using this product it may cause abdominal discomfort, faintness, rectal bleeding and mild cramps"
      ],
      "stop_use": [
        "Stop use and ask a doctor if ■ you have rectal bleeding ■ you fail to have a bowel movement after using this product. This 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. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions ■ detach one suppository from the strip ■ remove wrapper before inserting into the rectum adults and children 12 and over : 1 suppository once daily children 6 to under 12 years : ½ suppository once daily children under 6 years : do not use"
      ],
      "storage_and_handling": [
        "Other information ■ Store at room temperature. Do not exceed 30° C (86° F) ■ Lot No. & Exp. Date: see wrapper or box"
      ],
      "inactive_ingredient": [
        "Inactive ingredient hydrogenated vegetable oil"
      ],
      "questions": [
        "Questions? Adverse Drug Event Call: 1(877) 477-8633"
      ],
      "safe_handling_warning": [
        "Tamper evident seal: Do not use if wrapper on an individual suppository is broken or missing."
      ],
      "intended_use_of_the_device": [
        "Prompt, predictable relief from constipation"
      ],
      "package_label_principal_display_panel": [
        "Package Label Gentle Laxative Bisacodyl"
      ],
      "set_id": "03b3733a-4d78-149f-e063-6294a90a6518",
      "id": "2beb19bf-3d35-ed44-e063-6294a90a7eef",
      "effective_time": "20250117",
      "version": "2",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Gentle Laxative Bisacodyl"
        ],
        "generic_name": [
          "GENTLE LAXATIVE BISACODYL"
        ],
        "manufacturer_name": [
          "NeilMed Pharmaceuticals Inc"
        ],
        "product_ndc": [
          "13709-321"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "RECTAL"
        ],
        "substance_name": [
          "BISACODYL"
        ],
        "rxcui": [
          "198509"
        ],
        "spl_id": [
          "2beb19bf-3d35-ed44-e063-6294a90a7eef"
        ],
        "spl_set_id": [
          "03b3733a-4d78-149f-e063-6294a90a6518"
        ],
        "package_ndc": [
          "13709-321-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0705928160064"
        ],
        "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"
        ]
      }
    }
  ]
}