{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "HyVee Ultra Strength Gas Relief SOFTGEL Simethicone DIMETHICONE, UNSPECIFIED DIMETHICONE FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN PEPPERMINT OIL SORBITOL SORBITAN TITANIUM DIOXIDE 910"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "*Compare to the Active Ingredient of Gas-X ® Ultra Strength FOR THE RELIEF OF • Bloating • Pressure • Discomfort Associated with Gas READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266 PRODUCT OF INDIA SATISFACTION GUARANTEED OR PURCHASE PRICE REFUNDED FOR INFORMATION CALL 1-800-289-8343 www.hy-vee.com *This product is not manufactured or distributed by the Haleon US holdings LLC, owner of the registered trademark Gas-X ® . TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING."
      ],
      "active_ingredient": [
        "Active ingredient (in each softgel) Simethicone 180 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 or 2 softgels as needed after meals and at bedtime • do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician"
      ],
      "storage_and_handling": [
        "Other information • contains FD&C yellow no. 6 • store at 20-25°C (68-77°F) • protect from light, heat and moisture"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C yellow no. 6, gelatin, glycerin, peppermint oil, sorbitol sorbitan solution, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? 1-888-577-8033 Monday - Friday 8am - 4pm EST"
      ],
      "package_label_principal_display_panel": [
        "Packaging UltraStrength Gas Relief SOFTGEL"
      ],
      "set_id": "49808dc8-a26e-49f4-e063-6294a90a4796",
      "id": "69883948-6c3a-4440-b4f0-066eea85d70a",
      "effective_time": "20260821",
      "version": "2",
      "openfda": {
        "application_number": [
          "M002"
        ],
        "brand_name": [
          "HyVee Ultra Strength Gas Relief SOFTGEL"
        ],
        "generic_name": [
          "SIMETHICONE"
        ],
        "manufacturer_name": [
          "HyVee Inc"
        ],
        "product_ndc": [
          "42507-840"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIMETHICONE, UNSPECIFIED"
        ],
        "rxcui": [
          "252294"
        ],
        "spl_id": [
          "69883948-6c3a-4440-b4f0-066eea85d70a"
        ],
        "spl_set_id": [
          "49808dc8-a26e-49f4-e063-6294a90a4796"
        ],
        "package_ndc": [
          "42507-840-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0075450856835"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}