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  5. Label Information: Dialyvite 3000

FDA Label for Dialyvite 3000

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. INDICATIONS AND USAGE
    3. CONTRAINDICATIONS
    4. PRECAUTIONS
    5. ADVERSE REACTIONS
    6. DOSAGE AND ADMINISTRATION
    7. PRINCIPAL DISPLAY PANEL

Dialyvite 3000 Product Label

The following document was submitted to the FDA by the labeler of this product Hillestad Pharmaceuticals Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description



Dialyvite 3000 is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite 3000 is a small, round, light brown, clear-coated tablet, with debossed "H" on one side.

Each tablet contains:

Folic Acid.....3 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).....25 mg

Vitamin B12 (Methylcobalamin).....1 mg

Biotin.....300 mcg

Pantothenic Acid (Calcium Pantothenate).....10 mg

Zinc (Zinc Citrate).....15 mg

Selenium (Selenium Amino Acid Chelate).....70 mcg

Inactive ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Mono-and Diglycerides, Pharmaceutical Glaze, Carob (color), Starch, Calcium Stearate, Silicon Dioxide.



Indications And Usage



Dialyvite 3000 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 10542-014-09

Dialyvite 3000

Multivitamin Supplement for Dialysis Patients

90 Tablets



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