DIALYVITE 5000- ascorbic acid, tocopheryl acid succinate, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated

Dialyvite 5000 by

Drug Labeling and Warnings

Dialyvite 5000 by is a Prescription medication manufactured, distributed, or labeled by Hillestad Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DIALYVITE 5000 
ascorbic acid, tocopheryl acid succinate, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10542-011
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	50 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	5 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA)	Cobalamin	2 mg
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	25 mg
.alpha.-tocopherol succinate, d- (UNII: LU4B53JYVE) (.alpha.-tocopherol, d- - UNII:N9PR3490H9)	.alpha.-tocopherol, d-	30 [iU]
Selenocysteine (UNII: 0CH9049VIS) (Selenium - UNII:H6241UJ22B)	Selenium	70 ug

Inactive Ingredients
Ingredient Name	Strength
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
Color	purple	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: 10542-011-09	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2008
2	NDC: 10542-011-02	7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		05/01/2008

Labeler - Hillestad Pharmaceuticals USA (029291085)

Establishment
Name	Address	ID/FEI	Business Operations
Hillestad Pharmaceuticals USA		029291085	manufacture(10542-011) , label(10542-011)