FDA Label for Dialyvite
View Indications, Usage & Precautions
Dialyvite 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 is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite is a small, round, light pink, 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
Inactive ingredients:
Microcrystalline Cellulose, Croscarmellose Sodium, Mono- and Diglycerides, Starch, Hypromellose, Polyethylene Glycol, Calcium Stearate, Carmine (color).
Indications And Usage
Dialyvite 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 as directed by your physician, orally.
Principal Display Panel
NDC 10542-010-10
Dialyvite
Multivitamin Supplement for Dialysis Patients
100 Tablets
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