Label: DIALYVITE 5000- ascorbic acid, tocopheryl acid succinate, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated

  • NDC Code(s): 10542-011-02, 10542-011-09
  • Packager: Hillestad Pharmaceuticals USA
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated October 14, 2022

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  • DESCRIPTION

    Dialyvite 5000 is a prescription folic acid supplement with additional nutrients for kidney dialysis patients.  Dialyvite 5000 is a small, round, purple, coated tablet, with debossed "H" on one side.

    Each tablet contains:

    Folic Acid.....5 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).....50 mg

    Vitamin B12 (Methylcobalamin).....2 mg

    Biotin.....300 mcg

    Pantothenic Acid (Calcium Pantothenate).....10 mg

    Zinc (Zinc Citrate).....25 mg

    Selenium (Selenium Amino Acid Chelate).....70 mcg

    Inactive ingredients:

    Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Starch, Silicon Dioxide, Blueberry Extract (color), Calcium Stearate.


  • INDICATIONS AND USAGE

    Dialyvite 5000 is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.

  • CONTRAINDICATIONS

    This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

  • 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

    Allergic sensitizations have been reported following oral administration of folic acid.

    Consult your physician immediately if adverse side effects occur.

  • DOSAGE AND ADMINISTRATION

    Take one tablet per day or use as directed by your physician, orally.


  • PRINCIPAL DISPLAY PANEL

    NDC 10542-011-09

    Dialyvite 5000

    Multivitamin Supplement for Dialysis Patients

    90 Tablets

    Dialyvite 3000 PDP


  • INGREDIENTS AND APPEARANCE
    DIALYVITE 5000 
    ascorbic acid, tocopheryl acid succinate, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10542-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid100 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.5 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.7 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine50 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid5 mg
    Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin2 mg
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin300 ug
    Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid10 mg
    Zinc Citrate (UNII: K72I3DEX9B) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation25 mg
    .alpha.-tocopherol succinate, d- (UNII: LU4B53JYVE) (.alpha.-tocopherol, d- - UNII:N9PR3490H9) .alpha.-tocopherol, d-30 [iU]
    Selenocysteine (UNII: 0CH9049VIS) (Selenium - UNII:H6241UJ22B) Selenium70 ug
    Inactive Ingredients
    Ingredient NameStrength
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Shellac (UNII: 46N107B71O)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Blueberry (UNII: 253RUG1X1A)  
    Calcium Stearate (UNII: 776XM7047L)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10542-011-0990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2008
    2NDC:10542-011-027 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other05/01/2008
    Labeler - Hillestad Pharmaceuticals USA (029291085)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hillestad Pharmaceuticals USA029291085manufacture(10542-011) , pack(10542-011) , label(10542-011)
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