DIALYVITE 5000 - ascorbic acid, tocopheryl acid succinate, 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 5000

DESCRIPTION

Dialyvite 5000 is a prescription folic acid supplement with additional nutrients for kidney dialysis patients.  Dialyvite 5000 is a small, round, purple, coated tablet, with debossed "H" on one side.

Each tablet contains:

Folic Acid.....5 mg

Vitamin E (d-alpha Tocopheryl Acid Succinate).....30 IU

Vitamin C (Ascorbic Acid).....100 mg

Thiamine (Thiamine Mononitrate).....1.5 mg

Riboflavin.....1.7 mg

Niacinamide.....20 mg

Vitamin B6 (Pyridoxine HCl).....50 mg

Vitamin B12 (Methylcobalamin).....2 mg

Biotin.....300 mcg

Pantothenic Acid (Calcium Pantothenate).....10 mg

Zinc (Zinc Citrate).....25 mg

Selenium (Selenium Amino Acid Chelate).....70 mcg

Inactive ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Starch, Silicon Dioxide, Blueberry Extract (color), Calcium Stearate.


INDICATIONS AND USAGE

Dialyvite 5000 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 per day or use as directed by your physician, orally.


PRINCIPAL DISPLAY PANEL

NDC 10542-011-09

Dialyvite 5000

Multivitamin Supplement for Dialysis Patients

90 Tablets

Dialyvite 3000 PDP


DIALYVITE 5000 
ascorbic acid, tocopheryl acid succinate, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10542-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid100 mg
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) Pyridoxine50 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid5 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin2 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 Cation25 mg
.alpha.-tocopherol succinate, d- (UNII: LU4B53JYVE) (.alpha.-tocopherol, d- - UNII:N9PR3490H9) .alpha.-tocopherol, d-30 [iU]
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)  
Blueberry (UNII: 253RUG1X1A)  
Calcium Stearate (UNII: 776XM7047L)  
Product Characteristics
ColorpurpleScoreno score
ShapeROUNDSize11mm
FlavorImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10542-011-0990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2008
2NDC:10542-011-027 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/01/2008
Labeler - Hillestad Pharmaceuticals USA (029291085)
Establishment
NameAddressID/FEIBusiness Operations
Hillestad Pharmaceuticals USA029291085manufacture(10542-011) , label(10542-011)

Revised: 10/2019
Document Id: fd80ab9f-cf9d-4816-9e62-65a7cb07c02b
Set id: 97791f73-e0c5-45a6-8aed-f456a5466eaf
Version: 3
Effective Time: 20191024
 
Hillestad Pharmaceuticals USA