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Dialyvite Supreme D

Generic Name: folic acid and multi-vitamin
Dosage Form: tablet

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 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 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, d-) .alpha.-tocopherol, d- 30 [iU]
Thiamine Mononitrate (Thiamine Ion) Thiamine 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) Pantothenic Acid 10 mg
Zinc Citrate (Zinc Cation) Zinc Cation 15 mg
Selenocysteine (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 in 1 BOTTLE, PLASTIC
2 NDC:10542-009-02 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 09/08/2010
Labeler - Hillestad Pharmaceuticals USA (029291085)
Establishment
Name Address ID/FEI Operations
Hillestad Pharmaceuticals USA 029291085 manufacture(10542-009), label(10542-009)
Revised: 12/2015
 
Hillestad Pharmaceuticals USA
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