Label: DIALYVITE SUPREME D- ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated
- NDC Code(s): 10542-009-02, 10542-009-09
- 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 Supreme D is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite Supreme D is a small, round, light green, coated tablet, with debossed "H" on one side, and bisected on the other side.
Each tablet contains:
Folic Acid.....3 mg
Vitamin C (Ascorbic Acid).....100 mg
Vitamin D (Cholecalciferol).....2000 IU
Vitamin E (D-alpha-Tocopheryl Acid Succinate).....30 IU
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, Starch, Silicon Dioxide, Calcium Stearate, Chlorophyllin (color).
- INDICATIONS AND USAGE
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- ADVERSE REACTIONS
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INGREDIENTS AND APPEARANCE
DIALYVITE SUPREME D
ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10542-009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 100 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 2000 [iU] .alpha.-tocopherol succinate, d- (UNII: LU4B53JYVE) (.alpha.-tocopherol, d- - UNII:N9PR3490H9) .alpha.-tocopherol, d- 30 [iU] Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.5 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.7 mg Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 20 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 25 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 3 mg Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin 1 mg Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin 300 ug Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid 10 mg Zinc Citrate (UNII: K72I3DEX9B) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation 15 mg Selenocysteine (UNII: 0CH9049VIS) (Selenium - UNII:H6241UJ22B) Selenium 70 ug Inactive Ingredients Ingredient Name Strength Microcrystalline Cellulose (UNII: OP1R32D61U) Croscarmellose Sodium (UNII: M28OL1HH48) Glyceryl Monostearate (UNII: 230OU9XXE4) Shellac (UNII: 46N107B71O) Starch, Corn (UNII: O8232NY3SJ) Silicon Dioxide (UNII: ETJ7Z6XBU4) Calcium Stearate (UNII: 776XM7047L) Sodium Copper Chlorophyllin (UNII: 1D276TYV9O) Product Characteristics Color green Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10542-009-09 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/08/2010 2 NDC:10542-009-02 7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/08/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/08/2010 Labeler - Hillestad Pharmaceuticals USA (029291085) Establishment Name Address ID/FEI Business Operations Hillestad Pharmaceuticals USA 029291085 manufacture(10542-009) , pack(10542-009) , label(10542-009)