Prescription Drug Information: Dialyvite

DIALYVITE — ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cobalamin, biotin and calcium pantothenate tablet, coated
Atlantic Biologicals Corps

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.

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).

Dialyvite Indications and Usage

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.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Product: 17856-0010

NDC: 17856-0010-4 1 TABLET, COATED in a DOSE PACK

DIALYVITE (ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID) TABLET, COATED

Label Image
(click image for full-size original)
DIALYVITE
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0010(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
MICROCRYSTALLINE CELLULOSE
Croscarmellose Sodium
Glyceryl Monostearate
Starch, Corn
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
Calcium Stearate
Cochineal
Product Characteristics
Color pink Score no score
Shape ROUND Size 11mm
Flavor Imprint Code H
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-0010-4 100 DOSE PACK in 1 CONTAINER contains a DOSE PACK
1 1 TABLET, COATED in 1 DOSE PACK This package is contained within the CONTAINER (17856-0010-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/01/1988
Labeler — Atlantic Biologicals Corps (047437707)
Establishment
Name Address ID/FEI Operations
Atlantic Biologicals Corps 047437707 RELABEL (17856-0010), REPACK (17856-0010)

Revised: 05/2017 Atlantic Biologicals Corps

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