{
  "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": [
        "Simethicone Drops Simethicone Drops DIMETHICONE DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM ANHYDROUS CITRIC ACID MALTITOL MICROCRYSTALLINE CELLULOSE WATER SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information TAMPER-EVIDENT: Do not use if wrapper containing syringe is torn or open store at room temperature 20º-25ºC (68º-77ºF) do not freeze"
      ],
      "active_ingredient": [
        "Active ingredient (in each 0.6 mL unit-dose syringe) Simethicone 40 mg"
      ],
      "purpose": [
        "Purpose Antigas"
      ],
      "indications_and_usage": [
        "Use relieves the symptoms referred to as gas"
      ],
      "warnings": [
        "Warnings Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away."
      ],
      "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."
      ],
      "dosage_and_administration": [
        "Directions dose may be repeated as needed, after meals and at bedtime, or as directed by a physician only use the unit dose filled syringe. do not exceed 12 doses per day dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids discard syringe after use Age (years) Weight (lbs) Dose children (age 2 and over) 24 and over 0.6 mL"
      ],
      "dosage_and_administration_table": [
        "<table><col/><col/><col/><tbody><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">Age (years)</content></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">Weight (lbs) </content></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">Dose </content></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"> children (age 2 and over) </td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"> 24 and over</td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"> 0.6 mL</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive ingredients carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum"
      ],
      "questions": [
        "Questions or comments? 1-866-838-3774"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel NDC 84415-003-01 Simethicone (ENFIT) Oral Suspension, USP 40 mg/0.6 mL Distributed by: Everpharm LLC Marlborough MA 01752 50 UNITS x 0.6 mL pdp"
      ],
      "set_id": "5a6d2c1f-4067-969f-e063-6394a90aa83f",
      "id": "5a8782d0-df4d-f78b-e063-6394a90a6127",
      "effective_time": "20260902",
      "version": "2",
      "openfda": {
        "application_number": [
          "M002"
        ],
        "brand_name": [
          "Simethicone Drops"
        ],
        "generic_name": [
          "SIMETHICONE DROPS"
        ],
        "manufacturer_name": [
          "Everpharm LLC"
        ],
        "product_ndc": [
          "84415-003"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "198857"
        ],
        "spl_id": [
          "5a8782d0-df4d-f78b-e063-6394a90a6127"
        ],
        "spl_set_id": [
          "5a6d2c1f-4067-969f-e063-6394a90aa83f"
        ],
        "package_ndc": [
          "84415-003-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0384415003017"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}