PureVit DualFe Plus

Manufacturer
PureTek Corporation
Effective date
2023-01-11
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:46:08

Label at a glance#

ProductPureVit DualFe Plus
Active ingredientCUPRIC SULFATE, FERROUS FUMARATE, IRON DEXTRAN, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, SODIUM ASCORBATE, THIAMINE MONONITRATE, ZINC SULFATE, MANGANESE SULFATE
Label structure9 sections

Dosage and administration

Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

Label contents#

Full prescribing information#

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

PureVit DualFe Plus is unique in that it utilizes two different forms of iron, i.e., Ferrous Fumarate and Polysaccharide Iron Complex (as cell-contracted akaganeite), making available a total of 106 mg of elemental iron per capsule as follows:


Ferrous Fumarate (anhydrous) 162 mg

Polysaccharide Iron Complex (PIC) 115.2 mg



Subclinical B-Group vitamin deficiencies have greatly increased in recent years due to changes in dietetic habits, increase in the use of sugar, and the excessive milling of flour and cereals. With thiamine deficiencies so prevalent in a healthy populace, it is self-evident that the unwell person is particularly prone to thiamine avitaminosis. This is true of the anemic individual with his or her poor appetite and disturbed digestive functions. Folic acid is best known for its role in megaloblastic anemias. Zinc has been recognized in the nutrition of animals and humans, even though the evidence for an uncomplicated zinc deficiency in humans is limited.

Ferrous Fumarate: Provides about 53 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous salt of a combination of ferrous iron and fumaric acid, containing 33% of iron per weight. The acute toxicity in experimental animals is low and Ferrous Fumarate is well tolerated clinically. As a ferrous salt, it is more efficiently absorbed in the duodenum. Ferrous Fumarate contrasts very favorably with the availability of the 20% of elemental iron of ferrous sulfate, and the 13% of elemental iron of ferrous gluconate.

Polysaccharide Iron Complex: Provides about 53 mg of elemental iron, as a cell-contracted akaganeite. It is a product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is produced by extensive hydrolysis of starch and is a dark brown powder that dissolves in water to form a very dark brown solution, which is virtually odorless and tasteless.



Folic Acid:

Folic Acid is one of the most important hematopoetic agents necessary for proper regeneration of the blood-forming elements and their function. Folic acid is a precursor to a large family of compounds which serve as coenzymes in carbon transfer reactions. These reactions are required for the synthesis of purine and pyrimidine bases, inter-conversion of glycine and serine, biosynthesis of methionine methyl groups and degradation of histidine. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia.

INDICATIONS:

INDICATIONS & USAGE SECTION

PureVit DualFe Plus is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

PureVit DualFe Plus is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

WARNING:

WARNINGS SECTION

Accidental overdose of Iron-containing products is the leading cause of fatal poisoning of children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.

PRECAUTIONS:

PRECAUTIONS SECTION

General: Folic Acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations, remain progressive.

Pediatric Use:

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

GERIATRIC USE SECTION

No clinical studies have been performed in patients age 65 and over to determine whether older patients respond differently from younger patients. Dosage should always begin at the low end of the dosage scale and should consider that elderly patients may have decreased hepatic, renal or cardiac function, and of concomitant diseases.

Adverse Reactions:

ADVERSE REACTIONS SECTION

Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.

Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving PureVit DualFe Plus after meals may control occasional gastrointestinal disturbances. PureVit DualFe Plus is best absorbed when taken at bedtime.

Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

OVERDOSE:

OVERDOSAGE SECTION

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. PureVit DualFe Plus should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children.

Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

HOW SUPPLIED:

HOW SUPPLIED SECTION

PureVit DualFe Plus are yellow capsules imprinted horizontally "P-112", bottles of 90 capsules NDC 59088-112-66. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep in a cool, dry place.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of labelimage of label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
FERRIC CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
MANGANESE CATION (2+) Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59088-112-662020-03-18C16284748780-197431aae-1634-960c-e053-dbdaa90a7534PureVit DualFe Plus
59088-112-662019-11-13C16284748780-197431aae-1634-960c-e053-dbdaa90a7534PureVit DualFe Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-112-66PureVit DualFe Plus90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-112PUREVIT DUALFE PLUS (FERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEX) CAPSULE [PURETEK CORPORATION]3Current NDC, Legacy NDC, 1 package rows20230112_71f63741-cad4-43b5-bb3e-c63a188d10a2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-112-66EA - Each59088-1127e05dc4b-dbf6-423f-8164-6c1208eeadc512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM PANTOTHENATEACTIVE INGREDIENT568ET80C3D1
CUPRIC SULFATEACTIVE INGREDIENTLRX7AJ16DT1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0Q1
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
IRON DEXTRANACTIVE INGREDIENT95HR524N2M1
MANGANESE SULFATEACTIVE INGREDIENTW00LYS4T261
NIACINAMIDEACTIVE INGREDIENT25X51I8RD41
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR1
SODIUM ASCORBATEACTIVE INGREDIENTS033EH83591
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919X1
ZINC SULFATEACTIVE INGREDIENT89DS0H96TB1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R1
COPPERACTIVE MOIETY789U1901C51
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
FOLIC ACIDACTIVE MOIETY935E97BOY81
IRONACTIVE MOIETYE1UOL152H71
MANGANESEACTIVE MOIETY42Z2K6ZL8P1
NIACINACTIVE MOIETY2679MF687A1
PANTOTHENIC ACIDACTIVE MOIETY19F5HK27371
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
RIBOFLAVINACTIVE MOIETYTLM2976OFR1
THIAMINEACTIVE MOIETYX66NSO3N351
ZINC CATIONACTIVE MOIETY13S1S8SF371
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
GELATININACTIVE INGREDIENT2G86QN327L1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-11259088-112-66

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE / ORAL652 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE / ORAL652 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PureVit DualFe PlusFERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEXPureTek Corporation71f63741-cad4-43b5-bb3e-c63a188d10a22023-01-11Warnings, Adverse reactionsExact identifier
ndc (package): 59088-112-66
ndc (product): 59088-112
ndc11 (package): 59088011266
spl id: f2048b24-433b-98ba-e053-2995a90a5e85
spl set id: 71f63741-cad4-43b5-bb3e-c63a188d10a2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.