{
  "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": "2026-07-21",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Ultrastrength Gas Relief Simethicone Soft Gelatin Capsules SHELLAC DIMETHICONE DIMETHICONE GLYCERIN PEPPERMINT OIL SORBITAN FD&C YELLOW NO. 6 MEDIUM-CHAIN TRIGLYCERIDES SORBITOL WATER PROPYLENE GLYCOL TITANIUM DIOXIDE GELATIN 107 Orange opaque"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient (in each softgel) Simethicone 180 mg"
      ],
      "purpose": [
        "Purpose Anti-gas"
      ],
      "indications_and_usage": [
        "Use for the relief of pressure and bloating 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: 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"
      ],
      "other_safety_information": [
        "Other information store at room temperature protect from light, heat and moisture"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C yellow no. 6, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? Call 1-877-290-4008"
      ],
      "package_label_principal_display_panel": [
        "CVS_721T_50ct"
      ],
      "set_id": "24ceba32-eb30-902f-e063-6394a90a9fd5",
      "id": "2b082a35-29b6-345e-e063-6394a90a6246",
      "effective_time": "20250129",
      "version": "2",
      "openfda": {
        "application_number": [
          "M002"
        ],
        "brand_name": [
          "Ultrastrength Gas Relief"
        ],
        "generic_name": [
          "SIMETHICONE SOFT GELATIN CAPSULES"
        ],
        "manufacturer_name": [
          "CVS PHARMACY, INC"
        ],
        "product_ndc": [
          "51316-621"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "252294"
        ],
        "spl_id": [
          "2b082a35-29b6-345e-e063-6394a90a6246"
        ],
        "spl_set_id": [
          "24ceba32-eb30-902f-e063-6394a90a9fd5"
        ],
        "package_ndc": [
          "51316-621-76"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}