{
  "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": [
        "Gestyra ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL THIAMINE THIAMINE ION PYRIDOXAL PHOSPHATE ANHYDROUS PYRIDOXAL PHOSPHATE ANHYDROUS FOLIC ACID FOLIC ACID METHYLCOBALAMIN METHYLCOBALAMIN CALCIUM CARBONATE CALCIUM CATION FERROUS GLUCONATE FERROUS CATION POTASSIUM IODIDE IODIDE ION MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE"
      ],
      "description": [
        "DESCRIPTION Each Tablet Contains: Amount per Tablet Vitamin C (as ascorbic acid) ............................................................................... 125 mg Vitamin D (as cholecalciferol) ............................................................................. 12.5 mcg Thiamine (as hydrochloride) ............................................................................... 1.4 mg Vitamin B6 (as pyridoxal•S•phosphate) ...................................... ....................... 2.5 mg Folic Acid ............................................................................................................ 1 mg Vitamin B12 (as methylcobalamin)...................................................................... 1,000 mcg Calcium (from calcium carbonate) ...................................................................... 200 mg Iron (as ferrous gluconate) ................................................................................. 13 mg Iodine (as potassium iodide............................................................................... 150 mcg OTHER INGREDIENTS: Microcrystalline Cellulose, Magnesium Stearate, Silia, Glycerin, Vanilla Extract"
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Prenatal and Postnatal prescriptive Folic Acid"
      ],
      "warnings": [
        "WARNINGS WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately."
      ],
      "warnings_table": [
        "<table><col/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><content styleCode=\"bold\">WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately.</content><content styleCode=\"bold\"> </content></td></tr></tbody></table>"
      ],
      "precautions": [
        "PRECAUTIONS Call your licensed medical practitioner about side effects."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed practitioner."
      ],
      "how_supplied": [
        "HOW SUPPLIED Bottles of 30: 85477-922-30 Storage KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN."
      ],
      "storage_and_handling": [
        "Storage KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Gestyra PDP"
      ],
      "set_id": "f10bf225-c125-4711-893a-78e15be815bb",
      "id": "d8c1b301-80ad-4afa-9cf8-b0d8ddd6992c",
      "effective_time": "20251230",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Gestyra"
        ],
        "generic_name": [
          "ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE"
        ],
        "manufacturer_name": [
          "Oncora Pharma LLC"
        ],
        "product_ndc": [
          "85477-922"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ASCORBIC ACID",
          "CHOLECALCIFEROL",
          "THIAMINE",
          "PYRIDOXAL PHOSPHATE ANHYDROUS",
          "FOLIC ACID",
          "METHYLCOBALAMIN",
          "CALCIUM CARBONATE",
          "FERROUS GLUCONATE",
          "POTASSIUM IODIDE"
        ],
        "spl_id": [
          "d8c1b301-80ad-4afa-9cf8-b0d8ddd6992c"
        ],
        "spl_set_id": [
          "f10bf225-c125-4711-893a-78e15be815bb"
        ],
        "package_ndc": [
          "85477-922-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0385477000051"
        ],
        "nui": [
          "N0000193618",
          "M0001797",
          "M0022797",
          "N0000175952"
        ],
        "pharm_class_epc": [
          "Vitamin C [EPC]",
          "Vitamin D [EPC]"
        ],
        "pharm_class_cs": [
          "Ascorbic Acid [CS]",
          "Vitamin D [CS]"
        ],
        "unii": [
          "PQ6CK8PD0R",
          "1C6V77QF41",
          "X66NSO3N35",
          "F06SGE49M6",
          "935E97BOY8",
          "BR1SN1JS2W",
          "H0G9379FGK",
          "U1B11I423Z",
          "1C4QK22F9J"
        ]
      }
    }
  ]
}