Label: DIALYVITE- ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid tablet, coated

  • NDC Code(s): 10542-010-02, 10542-010-10
  • Packager: Hillestad Pharmaceuticals USA
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 22, 2019

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  • 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

    Dialyvite 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 as directed by your physician, orally.


  • PRINCIPAL DISPLAY PANEL


    NDC 10542-010-10

    Dialyvite

    Multivitamin Supplement for Dialysis Patients

    100 Tablets

    Dialyvite PDP

  • INGREDIENTS AND APPEARANCE
    DIALYVITE 
    ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10542-010
    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) Pyridoxine10 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin6 ug
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin300 ug
    Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid10 mg
    Inactive Ingredients
    Ingredient NameStrength
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Hypromellose, unspecified (UNII: 3NXW29V3WO)  
    Polyethylene Glycol, unspecified (UNII: 3WJQ0SDW1A)  
    Calcium Stearate (UNII: 776XM7047L)  
    Cochineal (UNII: TZ8Z31B35M)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10542-010-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/1988
    2NDC:10542-010-027 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/1988
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other08/01/1988
    Labeler - Hillestad Pharmaceuticals USA (029291085)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hillestad Pharmaceuticals USA029291085manufacture(10542-010) , label(10542-010)