Dialyvite With Zinc Tablet, Coated
FDA Label NDC 10542-012

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 With Zinc (NDC 10542-012). 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 with Zinc is a prescription folic acid supplement with zinc and additional nutrients for kidney dialysis patients.  Dialyvite with Zinc is a small, round, yellow, 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

Zinc (Zinc Citrate).....50 mg

Inactive ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Starch, Calcium Stearate.


Indications And Usage

Dialyvite with Zinc is a prescription folic acid supplement with Zinc and 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.


Principal Display Panel

NDC 10542-012-10

Dialyvite with Zinc

Multivitamin Supplement for Dialysis Patients

100 Tablets

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