Prenatrix
Ferrous Fumarate, Folic Acid
Puretek Corporation
Human Prescription Drug
NDC 59088-166Prenatrix also known as Ferrous Fumarate, Folic Acid is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Prenatrix is 59088-166. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Prenatrix drug includes .alpha.-tocopherol Acetate, Dl- - 30 mg/1 Ascorbic Acid - 120 mg/1 Calcium Carbonate - 200 mg/1 Cholecalciferol - 20 ug/1 Choline Bitartrate - 55 mg/1 Chromium Nicotinate - 45 ug/1 Cyanocobalamin - 10 ug/1 Ferrous Fumarate - 27 mg/1 Folic Acid - 1000 ug/1 Magnesium Oxide - 200 mg/1 and more. The currest status of Prenatrix drug is Active.
Drug Information:
| Drug NDC: | 59088-166 |
| 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: | Prenatrix |
| 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- - 30 mg/1 ASCORBIC ACID - 120 mg/1 CALCIUM CARBONATE - 200 mg/1 CHOLECALCIFEROL - 20 ug/1 CHOLINE BITARTRATE - 55 mg/1 CHROMIUM NICOTINATE - 45 ug/1 CYANOCOBALAMIN - 10 ug/1 FERROUS FUMARATE - 27 mg/1 FOLIC ACID - 1000 ug/1 MAGNESIUM OXIDE - 200 mg/1
Load more...MANGANESE SULFATE - 2.6 mg/1 MOLYBDENUM - 50 ug/1 NIACINAMIDE - 20 mg/1 POTASSIUM IODIDE - 150 ug/1 PYRIDOXINE HYDROCHLORIDE - 50 mg/1 RIBOFLAVIN - 3.4 mg/1 SELENIUM - 70 ug/1 THIAMINE MONONITRATE - 3 mg/1 VITAMIN A ACETATE - 1500 ug/1 ZINC OXIDE - 25 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: | 29 Aug, 2020 |
| 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. |
| UPC: | 0359088166543
|
| UPC stands for Universal Product Code. |
| 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 H0G9379FGK 1C6V77QF41 6K2W7T9V6Y A150AY412V P6YC3EG204 R5L488RY0Q 935E97BOY8 3A3U0GI71G
Load more...W00LYS4T26 81AH48963U 25X51I8RD4 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] Osmotic Activity [MoA] Osmotic Laxative [EPC] Paramagnetic Contrast Agent [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 |
|---|
| 59088-166-54 | 30 TABLET in 1 BOTTLE, PLASTIC (59088-166-54) | 29 Aug, 2020 | 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:
Prenatrix ferrous fumarate, folic acid magnesium oxide magnesium cation manganese sulfate manganese cation (2+) sodium ascorbate starch, corn magnesium stearate croscarmellose sodium microcrystalline cellulose gelatin 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 calcium carbonate calcium cation ferrous fumarate ferrous cation zinc oxide zinc cation aluminum starch octenylsuccinate butylated hydroxytoluene sucrose molybdenum molybdenum crospovidone medium-chain triglycerides choline bitartrate choline chromium nicotinate chromic cation stearic acid selenium selenium calcium phosphate, dibasic, dihydrate polyethylene glycol 400 hydroxymethyl cellulose silicon dioxide sodium aluminium silicate potassium iodide iodide ion (clear coated yellow to brown speckled) (oblong caplet) pt;a18
Drug Interactions:
Drug interactions: prenatrix 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 prenatrix after meals may control occasional gastrointestinal disturbances. prenatrix 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 idiosyncrat
Read more...ic reactions are possible at lower levels. iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
Boxed Warning:
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. precautions 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 neurologic 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.
Indications and Usage:
Indications prenatrix is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. prenatrix may be beneficial in improving the nutritional status of women prior to conception.
Dosage and Administration:
Dosage and administration: adults (persons over 12 years of age) one (1) prenatrix 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 prenatrix after meals may control occasional gastrointestinal disturbances. prenatrix 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 usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
Drug Interactions:
Drug interactions: prenatrix 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 prenatrix after meals may control occasional gastrointestinal disturbances. prenatrix 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 idiosyncrat
Read more...ic reactions are possible at lower levels. iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
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. prenatrix 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.
Description:
Description: \each caplet contains: vitamin a (as retinyl acetate)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦.. 1500 mcg vitamin c (as ascorbic acid)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦ 120 mg vitamin d3 (as cholecalciferol)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦ 20 mcg vitamin e (dl-alpha tocopheryl acetate)â¦â¦â¦â¦â¦â¦â¦â¦ 30 mg thiamin (as thiamine mononitrate)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦ 3 mg riboflavin (vitamin b2)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦. 3.4 mg niacin (as niacinamide)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦ 20 mg vitamin b6 (as pyridoxine hydrochloride)â¦â¦â¦â¦â¦â¦â¦. 50 mg folate (as folic acid)â¦â¦â¦.. 1700 mcg dfe (1000 mcg folic acid) vitamin b12 (as cyanocobalamin)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦ 10 mcg choline (as choline bitartrate)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦.. 55 mg calcium (as calcium carbonate)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦. 200 mg iron (as ferrous fumarate)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦ 27 mg iodine (as potassium iodine)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦.150 mcg magnesium (as magnesium oxide)â¦â¦â¦â¦â¦â¦â¦â¦â¦ 200 mg zinc (as zinc oxide)â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦.. 25 mg selenium (as selinium amino acid chelate)â¦â¦â¦â¦â¦â¦. 70 mcg manganese (as manganese sulfate)â¦â¦â¦â¦â¦â¦â¦â¦â¦ 2.6 mg chromium (as chromium polynicotinate)â¦â¦â¦â¦â¦â¦.. 45 mcg molybdenum (as molybdenum amino acid chelate)â¦â¦â¦ 50 mcg other ingredients: bht, dicalcium phosphate, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, clear coating: (hydroxypropyl methylcellulose, peg-8).
How Supplied:
How supplied prenatrix are yellow to brown speckled, oblong, coated caplets with "pt a18" debossed horizontally on one side, bottles containing 30 caplets â ndc 59088-166-54. dispense in a tight, light-resistant container as defined in the usp/nf with a child resistant closure. store at controlled room temperature 20° to 25°c (68° to 77°f). [see usp]. protect from light and moisture and avoid excessive heat.
Package Label Principal Display Panel:
Prenatrix manufactured in the usa by: puretek corporation panorama city, ca 91402 for questions or information call toll-free: 877-921-7873 label