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Dialyvite

Generic Name: ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cobalamin, biotin and calcium pantothenate
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 Description

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

Each tablet contains:

Folic Acid.....1 mg

Vitamin C (Ascorbic Acid).....100 mg

Thiamine (Thiamine Mononitrate).....1.5 mg

Riboflavin.....1.7 mg

Niacinamide.....20 mg

Vitamin B6 (Pyridoxine HCl).....10 mg

Vitamin B12 (Methylcobalamin).....6 mcg

Biotin.....300 mcg

Pantothenic Acid (Calcium Pantothenate).....10 mg

Inactive ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Mono- and Diglycerides, Starch, Hypromellose, Polyethylene Glycol, Calcium Stearate, Carmine (color).


Indications and Usage for Dialyvite

Dialyvite 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 Dosage and Administration

Take one tablet per day or as directed by your physician, orally.


PRINCIPAL DISPLAY PANEL


NDC 10542-010-10

Dialyvite

Multivitamin Supplement for Dialysis Patients

100 Tablets

Dialyvite 
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10542-010
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 10 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cobalamin (Cobalamin) Cobalamin 6 ug
Biotin (Biotin) Biotin 300 ug
Calcium Pantothenate (Pantothenic Acid) Pantothenic Acid 10 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, microcrystalline  
Croscarmellose Sodium  
Glyceryl Monostearate  
Starch, Corn  
Hypromelloses  
Polyethylene Glycols  
Calcium Stearate  
Cochineal  
Product Characteristics
Color pink Score no score
Shape ROUND Size 11mm
Flavor Imprint Code H
Contains         
Packaging
# Item Code Package Description
1 NDC:10542-010-10 100 TABLET, COATED in 1 BOTTLE, PLASTIC
2 NDC:10542-010-02 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 08/01/1988
Labeler - Hillestad Pharmaceuticals USA (029291085)
Establishment
Name Address ID/FEI Operations
Hillestad Pharmaceuticals USA 029291085 manufacture(10542-010), label(10542-010)
Revised: 12/2015
 
Hillestad Pharmaceuticals USA
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