Dialyvite 5000 Tablet, Coated
FDA Label NDC 10542-011

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hillestad Pharmaceuticals Usa for the product Dialyvite 5000 (NDC 10542-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications and usage, contraindications, precautions, adverse reactions, dosage and administration, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.


Principal Display Panel

NDC 10542-011-09

Dialyvite 5000

Multivitamin Supplement for Dialysis Patients

90 Tablets


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