Purevit Dualfe Plus
Ferrous Fumarate, Polysaccharide Iron Complex
Puretek Corporation
Human Prescription Drug
NDC 59088-112Purevit Dualfe Plus also known as Ferrous Fumarate, Polysaccharide Iron Complex is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Purevit Dualfe Plus is 59088-112. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Purevit Dualfe Plus drug includes Calcium Pantothenate - 10 mg/1 Cupric Sulfate - .8 mg/1 Cyanocobalamin - 15 ug/1 Ferrous Fumarate - 53 mg/1 Folic Acid - 1 mg/1 Iron Dextran - 53 mg/1 Manganese Sulfate - 1.3 mg/1 Niacinamide - 30 mg/1 Pyridoxine Hydrochloride - 5 mg/1 Riboflavin - 6 mg/1 and more. The currest status of Purevit Dualfe Plus drug is Active.
Drug Information:
| Drug NDC: | 59088-112 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Purevit Dualfe Plus |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Ferrous Fumarate, Polysaccharide Iron Complex |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Puretek Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CALCIUM PANTOTHENATE - 10 mg/1
CUPRIC SULFATE - .8 mg/1
CYANOCOBALAMIN - 15 ug/1
FERROUS FUMARATE - 53 mg/1
FOLIC ACID - 1 mg/1
IRON DEXTRAN - 53 mg/1
MANGANESE SULFATE - 1.3 mg/1
NIACINAMIDE - 30 mg/1
PYRIDOXINE HYDROCHLORIDE - 5 mg/1
RIBOFLAVIN - 6 mg/1
Load more...SODIUM ASCORBATE - 200 mg/1
THIAMINE MONONITRATE - 10 mg/1
ZINC SULFATE - 18.2 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jun, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | PureTek Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0731477171770
|
| UPC stands for Universal Product Code. |
| NUI: | M0022794
N0000175951
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 568ET80C3D
LRX7AJ16DT
P6YC3EG204
R5L488RY0Q
935E97BOY8
95HR524N2M
W00LYS4T26
25X51I8RD4
68Y4CF58BV
TLM2976OFR
Load more...S033EH8359
8K0I04919X
89DS0H96TB
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Vitamin B12 [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Vitamin B 12 [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Analogs/Derivatives [Chemical/Ingredient]
Ascorbic Acid [CS]
Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
Iron [CS]
Magnetic Resonance Contrast Activity [MoA]
Paramagnetic Contrast Agent [EPC]
Parenteral Iron Replacement [EPC]
Phosphate Binder [EPC]
Phosphate Chelating Activity [MoA]
Vitamin B 12 [CS]
Vitamin B 6 [Chemical/Ingredient]
Vitamin B12 [EPC]
Vitamin B6 Analog [EPC]
Vitamin C [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 59088-112-66 | 90 CAPSULE in 1 BOTTLE, PLASTIC (59088-112-66) | 01 Jun, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Purevit dualfe plus ferrous fumarate, polysaccharide iron complex cupric sulfate cupric cation ferrous fumarate ferrous cation silicon dioxide magnesium stearate gelatin titanium dioxide fd&c yellow no. 5 fd&c yellow no. 6 iron dextran ferric cation riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin calcium pantothenate pantothenic acid sodium ascorbate ascorbic acid thiamine mononitrate thiamine ion thiamine zinc sulfate zinc cation manganese sulfate manganese cation (2+) p112
Indications and Usage:
Indications: 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.
Warnings:
Warning: 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.
Dosage and Administration:
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.
Contraindications:
Contraindications: 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.
Adverse Reactions:
Adverse reactions: 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.
Pediatric Use:
Pediatric use: safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
Geriatric use: 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.
Overdosage:
Overdose: 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.
Clinical Pharmacology:
Clinical pharmacology: 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 l
Read more...imited. 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.
How Supplied:
How supplied: 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.
Package Label Principal Display Panel:
Label image of label