Dialyvite 5000

SPL v5

SPL

SPL Set ID 97791f73-e0c5-45a6-8aed-f456a5466eaf

Route

ORAL

Published

Effective Date 2026-01-27

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ascorbic Acid (100 mg) Riboflavin (1.5 mg) Niacinamide (1.7 mg) Pyridoxine (20 mg) Folic Acid (50 mg) Cobalamin (5 mg) Biotin (2 mg) Pantothenic Acid (300 ug) Zinc Cation (10 mg) .alpha.-tocopherol, D- (25 mg) Selenium (30 [iU])

Inactive Ingredients

Microcrystalline Cellulose Croscarmellose Sodium Glyceryl Monostearate Shellac Starch, Corn Silicon Dioxide Blueberry Calcium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: H Shape: round Color: purple Size: 11 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Completed Since 2008-05-01 Until 2027-02-28

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

Dialyvite 5000 is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.

Dosage and Administration

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

Contraindications

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

Adverse Reactions

Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

Medication Information

Indications and Usage

Dialyvite 5000 is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.

Dosage and Administration

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

Contraindications

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

Adverse Reactions

Allergic sensitizations have been reported following oral administration of folic acid.

Consult your physician immediately if adverse side effects occur.

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.

Precautions

Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress.

Keep out of reach of children.

Principal Display Panel

NDC 10542-011-09

Dialyvite 5000

Multivitamin Supplement for Dialysis Patients

90 Tablets

Structured Label Content

Description (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.

Precautions (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 (ADVERSE REACTIONS)

Allergic sensitizations have been reported following oral administration of folic acid.

Consult your physician immediately if adverse side effects occur.

Contraindications (CONTRAINDICATIONS)

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

Indications and Usage (INDICATIONS AND USAGE)

Dialyvite 5000 is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10542-011-09

Dialyvite 5000

Multivitamin Supplement for Dialysis Patients

90 Tablets

Dosage and Administration (DOSAGE AND ADMINISTRATION)

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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.", "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.", "CONTRAINDICATIONS": "This product is contraindicated in patients with known hypersensitivity to any of the ingredients.", "INDICATIONS AND USAGE": "Dialyvite 5000 is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.", "PRINCIPAL DISPLAY PANEL": "NDC 10542-011-09 Dialyvite 5000 Multivitamin Supplement for Dialysis Patients 90 Tablets", "DOSAGE AND ADMINISTRATION": "Take one tablet per day or use as directed by your physician, orally."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:52:50.899188 · Updated: 2026-03-14T22:44:52.002107