{
  "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": "2026-10-16",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Dialyvite Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid 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 Microcrystalline Cellulose Croscarmellose Sodium Glyceryl Monostearate Starch, Corn Hypromellose, unspecified Polyethylene Glycol, unspecified Calcium Stearate Cochineal H"
      ],
      "description": [
        "DESCRIPTION Dialyvite is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite is a small, round, light pink, clear-coated tablet, with debossed \"H\" on one side. Each tablet contains: Folic Acid.....1 mg Vitamin C (Ascorbic Acid).....100 mg Thiamine (Thiamine Mononitrate).....1.5 mg Riboflavin.....1.7 mg Niacinamide.....20 mg Vitamin B6 (Pyridoxine HCl).....10 mg Vitamin B12 (Methylcobalamin).....6 mcg Biotin.....300 mcg Pantothenic Acid (Calcium Pantothenate).....10 mg Inactive ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Mono- and Diglycerides, Starch, Hypromellose, Polyethylene Glycol, Calcium Stearate, Carmine (color)."
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Dialyvite 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 as directed by your physician, orally."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL NDC 10542-010-10 Dialyvite Multivitamin Supplement for Dialysis Patients 100 Tablets Dialyvite PDP"
      ],
      "set_id": "7a5e6dd6-5687-44bb-8964-841961c0e64a",
      "id": "c91498fd-0515-46a9-8a22-e423f554bd86",
      "effective_time": "20260127",
      "version": "5",
      "openfda": {
        "brand_name": [
          "Dialyvite"
        ],
        "generic_name": [
          "ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID"
        ],
        "manufacturer_name": [
          "Hillestad Pharmaceuticals USA"
        ],
        "product_ndc": [
          "10542-010"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ASCORBIC ACID",
          "THIAMINE MONONITRATE",
          "RIBOFLAVIN",
          "NIACINAMIDE",
          "PYRIDOXINE HYDROCHLORIDE",
          "FOLIC ACID",
          "COBALAMIN",
          "BIOTIN",
          "CALCIUM PANTOTHENATE"
        ],
        "spl_id": [
          "c91498fd-0515-46a9-8a22-e423f554bd86"
        ],
        "spl_set_id": [
          "7a5e6dd6-5687-44bb-8964-841961c0e64a"
        ],
        "package_ndc": [
          "10542-010-10",
          "10542-010-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0105420101006"
        ],
        "nui": [
          "N0000193618",
          "M0001797"
        ],
        "pharm_class_epc": [
          "Vitamin C [EPC]"
        ],
        "pharm_class_cs": [
          "Ascorbic Acid [CS]"
        ],
        "unii": [
          "PQ6CK8PD0R",
          "8K0I04919X",
          "TLM2976OFR",
          "25X51I8RD4",
          "68Y4CF58BV",
          "935E97BOY8",
          "8406EY2OQA",
          "6SO6U10H04",
          "568ET80C3D"
        ]
      }
    }
  ]
}