{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Helleborus comp. A Helleborus comp. A TIN TIN PHOSPHORUS PHOSPHORUS ARSENIC TRIOXIDE ARSENIC CATION (3+) WATER LEAD MONOSILICATE LEAD SILVER SILVER FORMICA RUFA FORMICA RUFA ANTIMONY ANTIMONY SODIUM CHLORIDE LACTOSE, UNSPECIFIED FORM HELLEBORUS NIGER ROOT HELLEBORUS NIGER ROOT POTASSIUM PHOSPHATE, MONOBASIC PHOSPHATE ION JUGLANS REGIA LEAF JUGLANS REGIA LEAF"
      ],
      "purpose": [
        "Use: Temporary relief of headache."
      ],
      "indications_and_usage": [
        "FOR ORAL USE ONLY"
      ],
      "dosage_and_administration": [
        "Directions: Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow. Follow inside instructions to open ampule."
      ],
      "warnings": [
        "Warnings: NOT FOR INJECTION Do not use if allergic to any ingredient. Contains traces of lactose. Consult a physician if symptoms worsen. If pregnant or nursing, consult a physician before use. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN."
      ],
      "active_ingredient": [
        "Active Ingredients: Helleborus (Christmas rose) 3X, Formica (Red wood ant) 6X, Kalium phos.(potassium dihydrogenphosphate) 6X,Stibium met. (Antimony) 6X, Juglans reg. e fol. et fruct (walnut) 7X, Argentum met. (Silver) 8X, Phosphorus (Yellow phosphorus) 12X, Arsenicum (White arsenic) 17X, Plumbum silicicum (Lead silicate) 20X"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Water, Salt, Lactose Prepared using rhythmical processes."
      ],
      "questions": [
        "Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 shopuriel.com Lot:"
      ],
      "package_label_principal_display_panel": [
        "Helleborus comp. A Ampules"
      ],
      "set_id": "150e57ad-3ed7-5cc9-e063-6394a90a25fe",
      "id": "4420fb70-8e19-709c-e063-6394a90a1e7a",
      "effective_time": "20251121",
      "version": "3",
      "openfda": {
        "brand_name": [
          "Helleborus comp. A"
        ],
        "generic_name": [
          "HELLEBORUS COMP. A"
        ],
        "manufacturer_name": [
          "Uriel Pharmacy Inc."
        ],
        "product_ndc": [
          "48951-5135"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ANTIMONY",
          "ARSENIC TRIOXIDE",
          "FORMICA RUFA",
          "HELLEBORUS NIGER ROOT",
          "JUGLANS REGIA LEAF",
          "LEAD MONOSILICATE",
          "PHOSPHORUS",
          "POTASSIUM PHOSPHATE, MONOBASIC",
          "SILVER",
          "TIN"
        ],
        "spl_id": [
          "4420fb70-8e19-709c-e063-6394a90a1e7a"
        ],
        "spl_set_id": [
          "150e57ad-3ed7-5cc9-e063-6394a90a25fe"
        ],
        "package_ndc": [
          "48951-5135-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9IT35J3UV3",
          "S7V92P67HO",
          "55H0W83JO5",
          "608DGJ6815",
          "85HKB87105",
          "TLE92T7F1J",
          "27YLU75U4W",
          "4J9FJ0HL51",
          "3M4G523W1G",
          "387GMG9FH5"
        ]
      }
    }
  ]
}