Dialyvite Supreme D

Generic Name: ascorbic acid, cholecalciferol, alpha-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cobalamin, biotin, calcium pantothenate, zinc citrate and selenium
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 Supreme D

Dialyvite Supreme D 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, Glyceryl Monostearate, Pharmaceutical Glaze, Starch, Silicon Dioxide, Calcium Stearate, Chlorophyllin.

Indications and Usage for Dialyvite Supreme D

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.

Dialyvite Supreme D 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



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 LABEL Item Code (Source) NDC:10542-009
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 100 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 2000 [iU]
Alpha-Tocopherol Succinate, D- (Alpha-Tocopherol) Alpha-Tocopherol Succinate, D- 30 [iU]
Thiamine Mononitrate (Thiamine) Thiamine Mononitrate 1.5 mg
Riboflavin (Riboflavin) Riboflavin 1.7 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg
Folic Acid (Folic Acid) Folic Acid 3 mg
Cobalamin (Cobalamin) Cobalamin 1 mg
Biotin (Biotin) Biotin 300 ug
Calcium Pantothenate (Pantothenic Acid) Calcium Pantothenate 10 mg
Zinc Citrate (Zinc) Zinc 15 mg
Selenium (Selenium) Selenium 70 ug
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Croscarmellose Sodium  
Glyceryl Monostearate  
Shellac  
Starch, Corn  
Silicon Dioxide  
Calcium Stearate  
Sodium Copper Chlorophyllin  
Product Characteristics
Color green Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code H
Contains         
Packaging
# Item Code Package Description
1 NDC:10542-009-09 90 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
2 NDC:10542-009-02 7 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
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 Operations
Hillestad Pharmaceuticals USA 029291085 manufacture
Revised: 04/2011
 
Hillestad Pharmaceuticals USA
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