{
  "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": "2026-10-27",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Stool Softener DOCUSATE CALCIUM DOCUSATE CALCIUM DOCUSATE CORN OIL FD&C RED NO. 40 GELATIN GLYCERIN WATER SORBITOL FD&C BLUE NO. 1 FD&C YELLOW NO. 6 SORBITAN SCU"
      ],
      "active_ingredient": [
        "Active ingredient (in each softgel) Docusate Calcium 240 mg Purpose Stool softener laxative"
      ],
      "purpose": [
        "Purpose Stool softener laxative",
        "Purpose Stool softener laxative"
      ],
      "indications_and_usage": [
        "Uses for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours"
      ],
      "warnings": [
        "Warnings Do not use if you are currently taking mineral oil, 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 lasts over 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 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 care 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 currently taking mineral oil, 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 lasts over 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 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 care 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 adults and children 12 years of age and over : take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information store between 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients corn oil, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, purified water, sorbitan sorbitol"
      ],
      "questions": [
        "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Compare to the active ingredient Surfak®†† Stool Softener DOCUSATE CALCIUM 240 mg / STOOL SOFTENER LAXATIVE Gentle relief of occasional constipation Take once a day Sodium free SOFTGELS ††This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Surfak®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION DISTRIBUTED BY:WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015",
        "Product Label WALGREENS Stool Softener Docusate Calcium 240 mg"
      ],
      "set_id": "2791223a-7ac0-47e5-9a6a-4d9a02cfeb63",
      "id": "563861bc-b844-403a-907b-d4f985a0da9e",
      "effective_time": "20240625",
      "version": "4",
      "openfda": {
        "application_number": [
          "M007"
        ],
        "brand_name": [
          "Stool Softener"
        ],
        "generic_name": [
          "DOCUSATE CALCIUM"
        ],
        "manufacturer_name": [
          "Walgreens"
        ],
        "product_ndc": [
          "0363-0868"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOCUSATE CALCIUM"
        ],
        "rxcui": [
          "1245376"
        ],
        "spl_id": [
          "563861bc-b844-403a-907b-d4f985a0da9e"
        ],
        "spl_set_id": [
          "2791223a-7ac0-47e5-9a6a-4d9a02cfeb63"
        ],
        "package_ndc": [
          "0363-0868-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0311917007038"
        ],
        "unii": [
          "6K7YS503HC"
        ]
      }
    }
  ]
}