{
  "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": "2026-09-29",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Gas-X Ultimate Strength Softgels Simethicone D&C RED NO. 27 ALUMINUM LAKE GELATIN, UNSPECIFIED GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES WATER SOYBEAN LECITHIN DIMETHICONE, UNSPECIFIED DIMETHICONE GX500"
      ],
      "active_ingredient": [
        "Active ingredient (in each softgel) Simethicone 500 mg"
      ],
      "purpose": [
        "Purpose Antigas"
      ],
      "indications_and_usage": [
        "Use for the relief of pressure, bloating, and fullness commonly referred to as gas"
      ],
      "warnings": [
        "Warning Keep out of reach of children."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Directions adults and children 12 years and older: swallow with water 1 softgel after meals or at bedtime do not exceed 1 softgel in 24 hours except under the advice and supervision of a physician"
      ],
      "storage_and_handling": [
        "Other information store at controlled room temperature 20-25ºC (68-77ºF) protect from light, heat and moisture"
      ],
      "inactive_ingredient": [
        "Inactive ingredients D&C red no. 27 aluminum lake, gelatin, glycerin, medium-chain triglycerides, pharmaceutical ink, purified water, soy lecithin"
      ],
      "questions": [
        "Questions or comments? 1-800-452-0051"
      ],
      "spl_unclassified_section": [
        "Additional information Gas-X Ultimate Strength Softgels offer fast, effective relief of pressure and bloating. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas. READ ALL PRODUCT INFORMATION BEFORE USING. KEEP CARTON FOR IMPORTANT INFORMATION. Gas-X Ultimate Strength Softgels contain liquid gas-fighting medicine in a softgels so they are easy to swallow. TAMPER EVIDENT FEATURE: Do not use if blister is broken or damaged. 1-800-452-0051 Dist. By: Haleon, Warren, NJ 07059 Trademarks owned or licensed by Haleon. ©2025 Haleon or licensor."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel NEW! HALEON #1 DOCTOR RECOMMENDED BRAND Gas-X SIMETHICONE 500 mg / ANTIGAS Goes to work in Minutes RELIEVES GAS FAST PRESSURE – BLOATING – DISCOMFORT ULTIMATE STRENGTH 2X STRONGER* STRONGEST OTC GAS RELIEF *Than 1 Gas-X Maximum Strength (250 mg) GX500 20 SoftGels Gas-X Ultimate Strength Softgels 20 count carton.jpg"
      ],
      "set_id": "24b777e5-f0b5-400d-8ca9-ae0c04b8503b",
      "id": "3597dc18-fb8f-a1e3-e063-6394a90a04ea",
      "effective_time": "20250520",
      "version": "1",
      "openfda": {
        "application_number": [
          "M002"
        ],
        "brand_name": [
          "Gas-X Ultimate Strength Softgels"
        ],
        "generic_name": [
          "SIMETHICONE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0067-8075"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIMETHICONE, UNSPECIFIED"
        ],
        "rxcui": [
          "2477951",
          "2716712"
        ],
        "spl_id": [
          "3597dc18-fb8f-a1e3-e063-6394a90a04ea"
        ],
        "spl_set_id": [
          "24b777e5-f0b5-400d-8ca9-ae0c04b8503b"
        ],
        "package_ndc": [
          "0067-8075-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}