Dialyvite 3000 tablet, coated

Description

Dialyvite 3000 is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite 3000 is a small, round, light brown, clear-coated tablet, with debossed "H" on one side.

Each tablet contains:

Folic Acid.....3 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).....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, Carob (color), Starch, Calcium Stearate, Silicon Dioxide.


Indications and usage

Dialyvite 3000 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.


Ingredients and appearance - Product information

Dialyvite 3000 tablet, coated- Ascorbic acid, tocopheryl acid succinate, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 10542-014
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ascorbic acid ( UNII: PQ6CK8PD0R)( Ascorbic acid - UNII: PQ6CK8PD0R ) 100 mgin 1
Thiamine mononitrate ( UNII: 8K0I04919X)( Thiamine ion - UNII: 4ABT0J945J ) 1.5 mgin 1
Riboflavin ( UNII: TLM2976OFR)( Riboflavin - UNII: TLM2976OFR ) 1.7 mgin 1
Niacinamide ( UNII: 25X51I8RD4)( Niacinamide - UNII: 25X51I8RD4 ) 20 mgin 1
Pyridoxine hydrochloride ( UNII: 68Y4CF58BV)( Pyridoxine - UNII: KV2JZ1BI6Z ) 25 mgin 1
Folic acid ( UNII: 935E97BOY8)( Folic acid - UNII: 935E97BOY8 ) 3 mgin 1
Cobalamin ( UNII: 8406EY2OQA)( Cobalamin - UNII: 8406EY2OQA ) 1 mgin 1
Biotin ( UNII: 6SO6U10H04)( Biotin - UNII: 6SO6U10H04 ) 300 ugin 1
Calcium pantothenate ( UNII: 568ET80C3D)( Pantothenic acid - UNII: 19F5HK2737 ) 10 mgin 1
Zinc citrate ( UNII: K72I3DEX9B)( Zinc cation - UNII: 13S1S8SF37 ) 15 mgin 1
.alpha.-tocopherol succinate, d- ( UNII: LU4B53JYVE)( .alpha.-tocopherol, d- - UNII: N9PR3490H9 ) 30 [iU]in 1
Selenocysteine ( UNII: 0CH9049VIS)( Selenium - UNII: H6241UJ22B ) 70 ugin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Croscarmellose sodium ( UNII: M28OL1HH48)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Carob ( UNII: 5MG5Z946UO)
Shellac ( UNII: 46N107B71O)
Starch, corn ( UNII: O8232NY3SJ)
Calcium stearate ( UNII: 776XM7047L)
Silicon dioxide ( UNII: ETJ7Z6XBU4)

Product Characteristics

Color brown Score 1
Shape ROUND Imprint Code H
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 10542-014-09 90 in 1 BOTTLE, PLASTIC 2004/02/01
2 NDC: 10542-014-02 7 in 1 BOTTLE, PLASTIC 2004/02/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
Unapproved drug other USA 2004/02/01

Labeler - Hillestad Pharmaceuticals USA( 029291085)

Establishment

Name ID/FEI Business Operations
Hillestad Pharmaceuticals USA 029291085 manufacture( 10542-014), label( 10542-014)

Principal display panel

NDC 10542-014-09

Dialyvite 3000

Multivitamin Supplement for Dialysis Patients

90 Tablets