{
  "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",
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  "results": [
    {
      "spl_product_data_elements": [
        "Docusate Sodium Docusate Sodium 100mg Docusate Sodium Docusate D&C RED NO. 33 FD&C Red No. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL TITANIUM DIOXIDE SCU2 Two-toned- white and clear red"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient (in each softgel) Docusate Sodium 100 mg"
      ],
      "purpose": [
        "Purpose Stool softener"
      ],
      "indications_and_usage": [
        "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours"
      ],
      "warnings": [
        "Warnings Do not use if you are presently taking mineral oil, unless told to do so 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 bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week 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 right away. (1-800-222-1222)"
      ],
      "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 bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a stool softener 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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"
      ],
      "dosage_and_administration": [
        "Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor"
      ],
      "dosage_and_administration_table": [
        "<table ID=\"i555fcda1-1eb0-42a1-89f2-824cb47412be\" width=\"418\" border=\"1\"><tbody><tr><td>adults and children 12 years and over </td><td>take 1-3 softgels daily</td></tr><tr><td>children 2 to under 12 years of age</td><td>take 1 softgel daily</td></tr><tr><td>children under 2 years</td><td>ask a doctor</td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information each softgel contains: sodium 6 mg VERY LOW SODIUM store at 25 o C (77 o F); excursions permitted between 15 o -30 o C (59 o -86 o F). keep tightly closed."
      ],
      "inactive_ingredient": [
        "Inactive ingredients D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)"
      ],
      "package_label_principal_display_panel": [
        "PHARBEST NDC 16103-0399-11 *Compare to the active ingredient of Colace ® Docusate Sodium Stool Softener 1000 SOFTGELS 100 mg each THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Docusate Sodium 100 mg Softgels Package Label"
      ],
      "set_id": "025e03e0-e273-47ed-87f7-98e388abe047",
      "id": "43b71fc6-6af3-4f45-a946-ab9cff49f5ba",
      "effective_time": "20260305",
      "version": "3",
      "openfda": {
        "application_number": [
          "M"
        ],
        "brand_name": [
          "Docusate Sodium"
        ],
        "generic_name": [
          "DOCUSATE SODIUM 100MG"
        ],
        "manufacturer_name": [
          "Pharbest Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "16103-399"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOCUSATE SODIUM"
        ],
        "rxcui": [
          "1115005"
        ],
        "spl_id": [
          "43b71fc6-6af3-4f45-a946-ab9cff49f5ba"
        ],
        "spl_set_id": [
          "025e03e0-e273-47ed-87f7-98e388abe047"
        ],
        "package_ndc": [
          "16103-399-08",
          "16103-399-11"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F05Q2T2JA0"
        ]
      }
    }
  ]
}