Vitafol Fe Plus

Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, Beta Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium

Exeltis Usa, Inc.
Human Prescription Drug
NDC 0642-7473

Vitafol Fe Plus also known as Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, Beta Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium is a human prescription drug labeled by 'Exeltis Usa, Inc.'. National Drug Code (NDC) number for Vitafol Fe Plus is 0642-7473. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Vitafol Fe Plus drug includes .alpha.-tocopherol Acetate, Dl- - 9 mg/1 Ascorbic Acid - 60 mg/1 Beta Carotene - 330 ug/1 Cholecalciferol - 25 mg/1 Cupric Oxide - 2 mg/1 Cyanocobalamin - 25 ug/1 Doconexent - 200 mg/1 Folic Acid - 680 mg/1 Iron - 90 mg/1 Levomefolate Calcium - 1020 ug/1 and more. The currest status of Vitafol Fe Plus drug is Active.

Drug Information:

Drug NDC:	0642-7473
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:	Vitafol Fe 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:	Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, Beta Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Exeltis Usa, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule, Liquid Filled
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- - 9 mg/1 ASCORBIC ACID - 60 mg/1 BETA CAROTENE - 330 ug/1 CHOLECALCIFEROL - 25 mg/1 CUPRIC OXIDE - 2 mg/1 CYANOCOBALAMIN - 25 ug/1 DOCONEXENT - 200 mg/1 FOLIC ACID - 680 mg/1 IRON - 90 mg/1 LEVOMEFOLATE CALCIUM - 1020 ug/1 Load more... MAGNESIUM OXIDE - 20 mg/1 NIACINAMIDE - 15 mg/1 POTASSIUM IODIDE - 150 ug/1 PYRIDOXINE HYDROCHLORIDE - 2.5 mg/1 RIBOFLAVIN - 1.8 mg/1 THIAMINE MONONITRATE - 1.6 mg/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:	15 Mar, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	19 Jan, 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:	Exeltis USA, Inc.
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 01YAE03M7J 1C6V77QF41 V1XJQ704R4 P6YC3EG204 ZAD9OKH9JC 935E97BOY8 E1UOL152H7 A9R10K3F2F Load more... 3A3U0GI71G 25X51I8RD4 1C4QK22F9J 68Y4CF58BV TLM2976OFR 8K0I04919X 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] Calculi Dissolution Agent [EPC] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 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
0642-7473-30	5 BLISTER PACK in 1 BOX, UNIT-DOSE (0642-7473-30) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	15 Mar, 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.

Other medicines with the same generic name

Vitafol Fe Plus

Doconexent & more..

Capsule, Liquid Filled
Exeltis USA, Inc.
NDC: 0642-7473

Product Elements:

Vitafol fe plus doconexent, niacinamide, .alpha.-tocopherol acetate, dl-, cholecalciferol, beta carotene, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc oxide, cupric oxide, potassium iodide, magnesium oxide, folic acid, and levomefolate calcium gelatin, unspecified sorbitol glycerin water yellow wax soybean oil lecithin, soybean titanium dioxide fd&c blue no. 1 fd&c red no. 40 sunflower oil tocopherol ascorbyl palmitate corn oil .alpha.-tocopherol, dl- medium-chain triglycerides doconexent doconexent niacinamide niacinamide .alpha.-tocopherol acetate, dl- .alpha.-tocopherol, dl- cholecalciferol cholecalciferol beta carotene beta carotene ascorbic acid ascorbic acid thiamine mononitrate thiamine ion thiamine riboflavin riboflavin pyridoxine hydrochloride pyridoxine cyanocobalamin cyanocobalamin iron iron zinc oxide zinc oxide cupric oxide cupric cation potassium iodide iodide ion magnesium oxide magnesium cation folic acid folic acid levomefolate calcium levomefolic acid ev0096

Drug Interactions:

Drug interactions medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. medications for hypertension used in conjunction with iodine supplementation may increase potassium levels in blood. high doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, valproic acid. folic acid may decrease a patient's response to methotrexate. vitamin d supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.

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 a poison control center immediately.

Indications and Usage:

Usage: vitafol Â® fe + prenatal supplement provides vitamin, mineral and omega-3 fatty acid supplementation throughout pregnancy, including individuals with known allergies to fish.* vitafol Â® fe + does not contain fish oils, fish proteins, or fish by-products.

Warnings:

Warnings/precautions: this product is intended for use as directed by your healthcare provider. do not share with others. vitafol Â® fe + must be used with caution in patients with known sensitivity or allergy to soy. vitamin d supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. high doses of vitamin d can lead to elevated levels of calcium that reside in the blood and soft tissues. bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. iodine should be used with caution in patients with an overactive thyroid. prolonged use of iron salts may produce iron storage disease. folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. the use of folic acid doses ab Read more...

ove 1 mg daily may precipitate or exacerbate the neurological damage of vitamin b12 deficiency. consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. supplemental intake of omega-3 fatty acids such as dha exceeding 2 grams per day is not recommended. avoid overdosage. keep out of the reach of children. drug interactions medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. medications for hypertension used in conjunction with iodine supplementation may increase potassium levels in blood. high doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, valproic acid. folic acid may decrease a patient's response to methotrexate. vitamin d supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. information for patients patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding. pediatric use not for pediatric use.

Dosage and Administration:

Directions for use: take one purple softgel capsule daily during pregnancy, or as directed by a physician.

Contraindications:

Contraindications: vitafol Â® fe + prenatal supplement is contraindicated in patients with hypersensitivity to any of its components or color additives. folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. iron supplementation is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin b12).

Adverse Reactions:

Adverse reactions: adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in vitafol Â® fe + . however, allergic and idiosyncratic reactions are possible at any dose. reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems. you should call your doctor for medical advice about adverse or unexpected reactions. to report to the company an adverse event or obtain product information, call 1-877-324-9349.

Drug Interactions:

Pediatric Use:

Pediatric use not for pediatric use.

Description:

Composition: each vitafol Â® fe+ softgel capsule contains: vitamin a (as beta carotene) 330 mcg rae vitamin c (as ascorbic acid) 60 mg vitamin d (as cholecalciferol) 25 mcg vitamin e (as dl-alpha tocopheryl acetate) 9 mg thiamin (vitamin b1 as thiamine mononitrate) 1.6 mg riboflavin (vitamin b2) 1.8 mg niacin (as niacinamide) 15 mg ne vitamin b6 (as pyridoxine hydrochloride) 2.5 mg folate 1700 mcg dfe (680 mcg dfe from folic acid & 1020 mcg dfe from l-methylfolate calcium) vitamin b12 (as cyanocobalamin) 25 mg iron (as polysaccharide iron complex) 90 mg iodine (as potassium iodide) 150 mcg magnesium (as magnesium oxide) 20 mg zinc (as zinc oxide) 25 mg copper (as copper oxide) 2 mg docosahexaenoic acid (dha) (from natural algal oil) 200 mg other ingredients: gelatin (bovine), soybean oil, glycerin, yellow beeswax, sorbitol, soy lecithin, titanium dioxide (color), fd&c red #40, fd&c blue #1 contains: soy

How Supplied:

How supplied: vitafol Â® fe + is available as a purple, oval shaped softgel capsule imprinted "ex0096". available in box of unit-dose pack of 30 (5 child resistant blister cards containing 6 softgel capsules) (0642-7473-30) and as professional samples (0642-7473-01). store at room temperature, approximately 15Â°-30Â°c (59Â°-86Â°f), avoid excessive heat above 30Â°c (86Â°f), light and moisture. please dispose of any unused capsules promptly, and properly.

Information for Patients:

Information for patients patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

Package Label Principal Display Panel:

Principal display panel - 30 capsule dose pack box 0642-7473-30 vitafol fe+ complete prenatal supplement with 90mg iron unit dose pack 30 softgel capsules r x dietary supplement u.s. patent pending principal display panel - 30 capsule dose pack box

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.