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Dialyvite 5000

Generic Name: ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cobalamin, biotin, calcium pantothenate, zinc citrate, .alpha.-tocopherol succinate, d- and selenocysteine
Dosage Form: tablet, coated

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.

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 for Dialyvite 5000

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.

Dialyvite 5000 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 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 LABEL Item Code (Source) NDC:10542-011
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 100 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.5 mg
Riboflavin (Riboflavin) Riboflavin 1.7 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 50 mg
Folic Acid (Folic Acid) Folic Acid 5 mg
Cobalamin (Cobalamin) Cobalamin 2 mg
Biotin (Biotin) Biotin 300 ug
Calcium Pantothenate (Pantothenic Acid) Pantothenic Acid 10 mg
Zinc Citrate (Zinc Cation) Zinc Cation 25 mg
.alpha.-tocopherol succinate, d- (.alpha.-tocopherol, d-) .alpha.-tocopherol, d- 30 [iU]
Selenocysteine (Selenium) Selenium 70 ug
Inactive Ingredients
Ingredient Name Strength
Cellulose, microcrystalline  
Croscarmellose Sodium  
Glyceryl Monostearate  
Shellac  
Starch, Corn  
Silicon Dioxide  
Blueberry  
Calcium Stearate  
Product Characteristics
Color purple Score no score
Shape ROUND Size 11mm
Flavor Imprint Code H
Contains         
Packaging
# Item Code Package Description
1 NDC:10542-011-09 90 TABLET, COATED in 1 BOTTLE, PLASTIC
2 NDC:10542-011-02 7 TABLET, COATED in 1 BOTTLE, PLASTIC
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 Operations
Hillestad Pharmaceuticals USA 029291085 manufacture(10542-011), label(10542-011)
Revised: 12/2015
 
Hillestad Pharmaceuticals USA
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