FDA Label for Dialyvite Supreme D
View Indications, Usage & Precautions
Dialyvite Supreme D 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 Supreme D is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite Supreme D is a small, round, light green, coated tablet, with debossed "H" on one side, and bisected on the other side.
Each tablet contains:
Folic Acid.....3 mg
Vitamin C (Ascorbic Acid).....100 mg
Vitamin D (Cholecalciferol).....2000 IU
Vitamin E (D-alpha-Tocopheryl Acid Succinate).....30 IU
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, Starch, Silicon Dioxide, Calcium Stearate, Chlorophyllin (color).
Indications And Usage
Dialyvite Supreme D 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 or as directed by your physician, orally.
Principal Display Panel
NDC 10542-009-09
Dialyvite Supreme D
Multivitamin Supplement for Dialysis Patients
90 Tablets
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