DIALYVITE WITH ZINC  - ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc tablet, coated 
Hillestad Pharmaceuticals USA

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

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

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 Code H
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) , label(10542-012)

Revised: 10/2019
Document Id: 7ce010c9-e131-468f-ac6c-652f16e13d84
Set id: 06508e37-5ae6-4a17-bf60-b3828c6082a7
Version: 3
Effective Time: 20191023
 
Hillestad Pharmaceuticals USA