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
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
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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
- CONTRAINDICATIONS
- PRECAUTIONS
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIALYVITE
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10542-010 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 Inactive Ingredients Ingredient Name Strength 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 Color pink 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:10542-010-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/1988 2 NDC:10542-010-02 7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/1988 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 08/01/1988 Labeler - Hillestad Pharmaceuticals USA (029291085) Establishment Name Address ID/FEI Business Operations Hillestad Pharmaceuticals USA 029291085 manufacture(10542-010) , pack(10542-010) , label(10542-010)
