{
  "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": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "SYMBIO FORTI DROPS Penicillium roqueforti WATER SODIUM CHLORIDE PENICILLIUM ROQUEFORTI PENICILLIUM ROQUEFORTI"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS: Penicillium roqueforti 4X"
      ],
      "warnings": [
        "WARNINGS: Do not use if the tamper evident strip is broken or removed from the base of the cap."
      ],
      "dosage_and_administration": [
        "DIRECTIONS: Take 5 – 10 drops orally, three times per day."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: Purified water USP, sodium chloride"
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN: KEEP OUT OF REACH OF CHILDREN: In case of overdose, get medical help or call a Poison Control Center right away."
      ],
      "indications_and_usage": [
        "INDICATIONS: This remedy is indicated for symptoms associated with gastrointestinal tract symbiosis restoration in cases of dysbacteria according to traditional homeopathic practice.*"
      ],
      "questions": [
        "QUESTIONS: Call toll-free from US & CA +1-844-880-4881 or visit our website www.biological-health.com"
      ],
      "purpose": [
        "PURPOSE: For internal indications according to traditional homeopathic practice."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast feeding... If pregnant or breast feeding, ask a health professional before use."
      ],
      "ask_doctor": [
        "ASK DOCTOR: Consult a physician if symptoms worsen or last for more than 7 days."
      ],
      "spl_unclassified_section": [
        "OTHER INFORMATION: Protect from light and heat. For professional distribution only. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL DISPLAY: Forti 4X"
      ],
      "set_id": "0786b213-5487-3c8f-e063-6394a90a9809",
      "id": "40e5d7f0-fbfd-a05b-e063-6394a90ae5d7",
      "effective_time": "20251011",
      "version": "3",
      "openfda": {
        "brand_name": [
          "SYMBIO FORTI DROPS"
        ],
        "generic_name": [
          "PENICILLIUM ROQUEFORTI"
        ],
        "manufacturer_name": [
          "Symbiopathic"
        ],
        "product_ndc": [
          "69710-185"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PENICILLIUM ROQUEFORTI"
        ],
        "spl_id": [
          "40e5d7f0-fbfd-a05b-e063-6394a90ae5d7"
        ],
        "spl_set_id": [
          "0786b213-5487-3c8f-e063-6394a90a9809"
        ],
        "package_ndc": [
          "69710-185-11"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185372",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0008890",
          "M0000728"
        ],
        "pharm_class_epc": [
          "Non-Standardized Fungal Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Fungal Proteins [CS]",
          "Allergens [CS]"
        ],
        "unii": [
          "7ORP6R724L"
        ]
      }
    }
  ]
}