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Dialyvite with Zinc Prescribing Information

Package insert / product label
Generic name: ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cobalamin, biotin, calcium pantothenate and zinc citrate
Dosage form: tablet, coated
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Oct 19, 2022.

Dialyvite with Zinc 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 for Dialyvite with Zinc

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/Side Effects

Allergic sensitizations have been reported following oral administration of folic acid.

Consult your physician immediately if adverse side effects occur.

Dialyvite with Zinc 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

Dialyvite with Zinc PDP
DIALYVITE WITH ZINC
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10542-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid100 mg
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.5 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.7 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine10 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin6 ug
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin300 ug
Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid10 mg
Zinc Citrate (UNII: K72I3DEX9B) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation50 mg
Inactive Ingredients
Ingredient NameStrength
Microcrystalline Cellulose (UNII: OP1R32D61U)
Croscarmellose Sodium (UNII: M28OL1HH48)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Shellac (UNII: 46N107B71O)
Starch, Corn (UNII: O8232NY3SJ)
Calcium Stearate (UNII: 776XM7047L)
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeH
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10542-012-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2002
2NDC:10542-012-027 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/01/2002
Labeler - Hillestad Pharmaceuticals USA (029291085)
Establishment
NameAddressID/FEIBusiness Operations
Hillestad Pharmaceuticals USA029291085manufacture(10542-012) , pack(10542-012) , label(10542-012)