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Dialyvite 5000 Package Insert

Status:
Prescription (Rx) Facts
Strength:
100 mg, 1.5 mg, 1.7 mg, 20 mg, 50 mg, 5 mg, 2 mg, 300 mcg, 10 mg, 25 mg, 30 IU, 70 mcg

Prescribing information (package insert) - Dialyvite 5000

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.

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 use as directed by your physician, orally.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for Dialyvite 5000

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Copper Absorption Inhibitor, Vitamin B6 Analog, Vitamin C
Active ingredients Ascorbic acid 100 mg, Thiamine mononitrate 1.5 mg, Riboflavin 1.7 mg, Niacinamide 20 mg, Pyridoxine hydrochloride 50 mg, Folic acid 5 mg, Cobalamin 2 mg, Biotin 300 mcg, Calcium pantothenate 10 mg, Zinc citrate 25 mg, Alpha-tocopherol succinate, d- 30 IU, Selenocysteine 70 mcg
Dosage form Tablet, coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) Hillestad Pharmaceuticals USA
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg, 1.5 mg, 1.7 mg, 20 mg, 50 mg, 5 mg, 2 mg, 300 mcg, 10 mg, 25 mg, 30 IU, 70 mcg – 90 in 1 bottle, plastic NDC 10542-011-09
100 mg, 1.5 mg, 1.7 mg, 20 mg, 50 mg, 5 mg, 2 mg, 300 mcg, 10 mg, 25 mg, 30 IU, 70 mcg – 7 in 1 bottle, plastic NDC 10542-011-02

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.