Label: DIALYVITE 3000- ascorbic acid, tocopheryl acid succinate, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated

  • NDC Code(s): 10542-014-02, 10542-014-09
  • Packager: Hillestad Pharmaceuticals USA
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 24, 2019

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  • 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

    Dialyvite 3000 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 10542-014-09

    Dialyvite 3000

    Multivitamin Supplement for Dialysis Patients

    90 Tablets

    Dialyvite 3000 PDP


  • INGREDIENTS AND APPEARANCE
    DIALYVITE 3000 
    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:10542-014
    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) Pyridoxine25 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid3 mg
    Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin1 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 Cation15 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)  
    Carob (UNII: 5MG5Z946UO)  
    Shellac (UNII: 46N107B71O)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Calcium Stearate (UNII: 776XM7047L)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10542-014-0990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2004
    2NDC:10542-014-027 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other02/01/2004
    Labeler - Hillestad Pharmaceuticals USA (029291085)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hillestad Pharmaceuticals USA029291085manufacture(10542-014) , label(10542-014)