{
  "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": "2026-05-01",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Dialyvite 3000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium Ascorbic Acid Ascorbic Acid Thiamine Mononitrate Thiamine Ion Thiamine Riboflavin Riboflavin Niacinamide Niacinamide Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid Cobalamin Cobalamin Biotin Biotin Calcium Pantothenate Pantothenic Acid Zinc Citrate Zinc Cation .alpha.-tocopherol succinate, d- .alpha.-tocopherol, d- Selenocysteine Selenium Microcrystalline Cellulose Croscarmellose Sodium Glyceryl Monostearate Carob Shellac Starch, Corn Calcium Stearate Silicon Dioxide H"
      ],
      "description": [
        "DESCRIPTION Dialyvite 3000 is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite 3000 is a small, round, light brown, clear-coated tablet, with debossed \"H\" on one side. Each tablet contains: Folic Acid.....3 mg Vitamin E (d-alpha Tocopheryl Acid Succinate).....30 IU Vitamin C (Ascorbic Acid).....100 mg Thiamine (Thiamine Mononitrate).....1.5 mg Riboflavin.....1.7 mg Niacinamide.....20 mg Vitamin B6 (Pyridoxine HCl).....25 mg Vitamin B12 (Methylcobalamin).....1 mg Biotin.....300 mcg Pantothenic Acid (Calcium Pantothenate).....10 mg Zinc (Zinc Citrate).....15 mg Selenium (Selenium Amino Acid Chelate).....70 mcg Inactive ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Carob (color), Starch, Calcium Stearate, Silicon Dioxide."
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Dialyvite 3000 is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients."
      ],
      "contraindications": [
        "CONTRAINDICATIONS This product is contraindicated in patients with known hypersensitivity to any of the ingredients."
      ],
      "precautions": [
        "PRECAUTIONS Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress. Keep out of reach of children."
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION Take one tablet per day or use as directed by your physician, orally."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL NDC 10542-014-09 Dialyvite 3000 Multivitamin Supplement for Dialysis Patients 90 Tablets Dialyvite 3000 PDP"
      ],
      "set_id": "0bf5d3b9-5931-4180-9517-19977b58fe9a",
      "id": "ccf8878c-fbe7-43cc-b317-af65b5d9ed1b",
      "effective_time": "20270127",
      "version": "6",
      "openfda": {
        "brand_name": [
          "Dialyvite 3000"
        ],
        "generic_name": [
          "ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUM"
        ],
        "manufacturer_name": [
          "Hillestad Pharmaceuticals USA"
        ],
        "product_ndc": [
          "10542-014"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          ".ALPHA.-TOCOPHEROL SUCCINATE, D-",
          "ASCORBIC ACID",
          "BIOTIN",
          "CALCIUM PANTOTHENATE",
          "COBALAMIN",
          "FOLIC ACID",
          "NIACINAMIDE",
          "PYRIDOXINE HYDROCHLORIDE",
          "RIBOFLAVIN",
          "SELENOCYSTEINE",
          "THIAMINE MONONITRATE",
          "ZINC CITRATE"
        ],
        "spl_id": [
          "ccf8878c-fbe7-43cc-b317-af65b5d9ed1b"
        ],
        "spl_set_id": [
          "0bf5d3b9-5931-4180-9517-19977b58fe9a"
        ],
        "package_ndc": [
          "10542-014-09",
          "10542-014-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0105420140906"
        ],
        "nui": [
          "N0000193618",
          "M0001797"
        ],
        "pharm_class_epc": [
          "Vitamin C [EPC]"
        ],
        "pharm_class_cs": [
          "Ascorbic Acid [CS]"
        ],
        "unii": [
          "LU4B53JYVE",
          "PQ6CK8PD0R",
          "6SO6U10H04",
          "568ET80C3D",
          "8406EY2OQA",
          "935E97BOY8",
          "25X51I8RD4",
          "68Y4CF58BV",
          "TLM2976OFR",
          "0CH9049VIS",
          "8K0I04919X",
          "K72I3DEX9B"
        ]
      }
    }
  ]
}