FDA Label for Dialyvite With Zinc

View Indications, Usage & Precautions

Dialyvite With Zinc 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 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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