![DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED [ATLANTIC BIOLOGICALS CORPS]](https://medic.hrt.org//dailymed/images/24d0f7d8-1409-452b-8fec-ce471e89f85e/lbl178560010.jpg)
| NDC | 17856-0010-4 |
| Set ID | 24d0f7d8-1409-452b-8fec-ce471e89f85e |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Atlantic Biologicals Corps |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
-
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
- HOW SUPPLIED
- DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED
-
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:17856-0010(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:17856-0010-4 100 in 1 CONTAINER 05/01/2017 1 1 in 1 DOSE PACK ; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 08/01/1988 Labeler - Atlantic Biologicals Corps (047437707) Establishment Name Address ID/FEI Business Operations Atlantic Biologicals Corps 047437707 RELABEL(17856-0010) , REPACK(17856-0010)
