Folitin-z
Ferrous Fumarate, Folic Acid
Puretek Corporation
Human Prescription Drug
NDC 59088-181Folitin-z also known as Ferrous Fumarate, Folic Acid is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Folitin-z is 59088-181. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Folitin-z drug includes .alpha.-tocopherol Acetate, Dl- - 45 mg/1 Ascorbic Acid - 250 mg/1 Biotin - 100 ug/1 Boron - 25 ug/1 Calcium Carbonate - 75 mg/1 Cholecalciferol - 13.75 ug/1 Chromium Nicotinate - 37.5 ug/1 Cuprous Oxide - 1 mg/1 Cyanocobalamin - 13 ug/1 Ferrous Fumarate - 9 mg/1 and more. The currest status of Folitin-z drug is Active.
Drug Information:
| Drug NDC: | 59088-181 |
| 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: | Folitin-z |
| 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, Folic Acid |
| 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: | Tablet |
| 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: | .ALPHA.-TOCOPHEROL ACETATE, DL- - 45 mg/1
ASCORBIC ACID - 250 mg/1
BIOTIN - 100 ug/1
BORON - 25 ug/1
CALCIUM CARBONATE - 75 mg/1
CHOLECALCIFEROL - 13.75 ug/1
CHROMIUM NICOTINATE - 37.5 ug/1
CUPROUS OXIDE - 1 mg/1
CYANOCOBALAMIN - 13 ug/1
FERROUS FUMARATE - 9 mg/1
Load more...FOLIC ACID - 500 ug/1
MAGNESIUM OXIDE - 37.5 mg/1
MANGANESE SULFATE - .75 mg/1
MOLYBDENUM - 25 ug/1
NIACINAMIDE - 22.5 mg/1
PANTOTHENIC ACID - 15 mg/1
POTASSIUM CHLORIDE - 24.5 mg/1
POTASSIUM IODIDE - 25 ug/1
PYRIDOXINE HYDROCHLORIDE - 6 mg/1
RIBOFLAVIN - 3.35 mg/1
SELENIUM - 30 ug/1
THIAMINE MONONITRATE - 3.25 mg/1
VITAMIN A ACETATE - 1500 ug/1
ZINC OXIDE - 15 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: | 11 Feb, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| 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. |
| NUI: | N0000193618
M0001797
M0022797
N0000175952
M0022794
N0000175951
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | WR1WPI7EW8
PQ6CK8PD0R
6SO6U10H04
N9E3X5056Q
H0G9379FGK
1C6V77QF41
A150AY412V
T8BEA5064F
P6YC3EG204
R5L488RY0Q
Load more...935E97BOY8
3A3U0GI71G
W00LYS4T26
81AH48963U
25X51I8RD4
19F5HK2737
660YQ98I10
1C4QK22F9J
68Y4CF58BV
TLM2976OFR
H6241UJ22B
8K0I04919X
3LE3D9D6OY
SOI2LOH54Z
|
| 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 C [EPC]
Vitamin D [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: | Ascorbic Acid [CS]
Vitamin D [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]
Blood Coagulation Factor [EPC]
Calcium [CS]
Calculi Dissolution Agent [EPC]
Cations
Divalent [CS]
Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
Increased Coagulation Factor Activity [PE]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Magnetic Resonance Contrast Activity [MoA]
Nicotinic Acid [EPC]
Nicotinic Acids [CS]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Paramagnetic Contrast Agent [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Vitamin A [CS]
Vitamin A [EPC]
Vitamin B 12 [CS]
Vitamin B 6 [Chemical/Ingredient]
Vitamin B12 [EPC]
Vitamin B6 Analog [EPC]
Vitamin C [EPC]
Vitamin D [CS]
Vitamin D [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 |
|---|
| 59088-181-58 | 60 TABLET in 1 BOTTLE, PLASTIC (59088-181-58) | 11 Feb, 2021 | 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:
Folitin-z ferrous fumarate, folic acid microcrystalline cellulose crospovidone silicon dioxide magnesium stearate carboxymethylcellulose sodium, unspecified dextrose monohydrate titanium dioxide icodextrin stearic acid fd&c yellow no. 6 vitamin a acetate vitamin a ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol acetate, dl- .alpha.-tocopherol, dl- thiamine mononitrate thiamine ion thiamine riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin biotin biotin pantothenic acid pantothenic acid calcium carbonate calcium cation ferrous fumarate ferrous cation potassium iodide iodide ion magnesium oxide magnesium cation zinc oxide zinc cation selenium selenium cuprous oxide cuprous oxide manganese sulfate manganese cation (2+) chromium nicotinate niacin molybdenum molybdenum potassium chloride potassium cation boron boron with slightly brown specks oblong caplet
Drug Interactions:
Drug interactions: folitin-z tm is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. there is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., aspirin, heparin, or clopidogrel).
Indications and Usage:
Indications: folitin-z tm 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 the treatment of the condition in which iron deficiency and vitamin c deficiency occurs 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 a leading cause of fatal poisoning in children under 6. keep this product out of reach of children. in case of accidental overdose, call a doctor or poison control center immediately. administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin b12 is deficient. precaution section folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. there is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. this may result in severe nervous system damage before the correct diagnosis is made. adequate doses of vitamin b12 may prevent, halt, or improve the neur
Read more...ologic changes caused by pernicious anemia. the patientâs medical conditions and consumption of other drugs, herbs, and/or supplements should be considered. for use on the order of a healthcare practitioner. call your doctor about side effects. to report side effects, call puretek corporation at 1-877-921-7873 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. drug interactions: folitin-z tm is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. there is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., aspirin, heparin, or clopidogrel). 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 folitin-z tm after meals may control occasional gastrointestinal disturbances. folitin-z tm is best absorbed when taken at bedtime. adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. however, allergic and idiosyncratic reactions are possible at lower levels. iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.
Dosage and Administration:
Dosage and administration: adults (persons over 12 years of age) two (2) folitin-z tm caplet daily, between meals or as directed by a physician. do not administer to children under the age of 12.
Contraindications:
Contraindications: this product 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 folitin-z tm after meals may control occasional gastrointestinal disturbances. folitin-z tm is best absorbed when taken at bedtime. adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. however, allergic and idiosyncratic reactions are possible at lower levels. iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.
Drug Interactions:
Drug interactions: folitin-z tm is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. there is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., aspirin, heparin, or clopidogrel).
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. folitin-z tm 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.
Description:
Description: full prescribing information: each serving size of 2 caplets contain: other ingredients: microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, coating:(sodium carboxymethylcellulose, dextrose monohydrate, titanium dioxide, dextrin, purified stearic acid, fd&c yellow #6/sunset yellow fcf aluminum lake). supplement facts
How Supplied:
How supplied: folitin-z tm are yellow with slightly brown speckled, coated caplets. bottles contain 60 caplets â ndc 59088-181-58. dispense in a tight, light-resistant container as defined in the usp/nf with a child-resistant closure.
Package Label Principal Display Panel:
Folitin-z tm manufactured in the usa by: puretek corporation panorama city, ca 91402 questions? call toll-free: 1-877-921-7873 label