DIALYVITE SUPREME D - ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated 
Hillestad Pharmaceuticals USA

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.

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Dialyvite Supreme D

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

Dialyvite Supreme D 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 or as directed by your physician, orally.


PRINCIPAL DISPLAY PANEL

NDC 10542-009-09

Dialyvite Supreme D

Multivitamin Supplement for Dialysis Patients

90 Tablets



Dialyvite Supreme D PDP

DIALYVITE SUPREME D 
ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10542-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid100 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol2000 [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) 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) Pyridoxine Hydrochloride25 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid3 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin1 mg
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin300 ug
Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid10 mg
Zinc Citrate (UNII: K72I3DEX9B) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation15 mg
Selenocysteine (UNII: 0CH9049VIS) (Selenium - UNII:H6241UJ22B) Selenium70 ug
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScore2 pieces
ShapeROUNDSize11mm
FlavorImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10542-009-0990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/08/2010
2NDC:10542-009-027 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/08/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/08/2010
Labeler - Hillestad Pharmaceuticals USA (029291085)
Establishment
NameAddressID/FEIBusiness Operations
Hillestad Pharmaceuticals USA029291085manufacture(10542-009) , label(10542-009)

Revised: 10/2019
Document Id: ae8848c7-abed-4437-a9cc-9607fb4b4d96
Set id: 46fc3acf-1e6d-4830-ae9a-abd9c1132fca
Version: 6
Effective Time: 20191024
 
Hillestad Pharmaceuticals USA