Label: DIALYVITE WITH ZINC- ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc tablet, coated
- NDC Code(s): 10542-012-02, 10542-012-10
- 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 14, 2022
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DESCRIPTION
Dialyvite with Zinc is a prescription folic acid supplement with zinc and additional nutrients for kidney dialysis patients. Dialyvite with Zinc is a small, round, yellow, 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
Zinc (Zinc Citrate).....50 mg
Inactive ingredients:
Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Starch, Calcium Stearate.
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INGREDIENTS AND APPEARANCE
DIALYVITE WITH ZINC
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10542-012 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 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 10 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin 6 ug 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 50 mg Inactive Ingredients Ingredient Name Strength Microcrystalline Cellulose (UNII: OP1R32D61U) Croscarmellose Sodium (UNII: M28OL1HH48) Glyceryl Monostearate (UNII: 230OU9XXE4) Shellac (UNII: 46N107B71O) Starch, Corn (UNII: O8232NY3SJ) Calcium Stearate (UNII: 776XM7047L) Product Characteristics Color yellow Score no score Shape ROUND Size 11mm Flavor Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10542-012-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2002 2 NDC:10542-012-02 7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 10/01/2002 Labeler - Hillestad Pharmaceuticals USA (029291085) Establishment Name Address ID/FEI Business Operations Hillestad Pharmaceuticals USA 029291085 manufacture(10542-012) , pack(10542-012) , label(10542-012)
