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

Dialyvite Supreme D by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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 Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10542-009
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
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	2000 [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)	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 Hydrochloride	25 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	3 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA)	Cobalamin	1 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	15 mg
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)
Calcium Stearate (UNII: 776XM7047L)
Sodium Copper Chlorophyllin (UNII: 1D276TYV9O)

Product Characteristics
Color	green	Score	2 pieces
Shape	ROUND	Size	11mm
Flavor		Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10542-009-09	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/08/2010
2	NDC: 10542-009-02	7 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/08/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/08/2010

Labeler - Hillestad Pharmaceuticals USA (029291085)

Establishment
Name	Address	ID/FEI	Business Operations
Hillestad Pharmaceuticals USA		029291085	manufacture(10542-009) , label(10542-009)