Strovite One Caplets

Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .alpha.-lipoic Acid, And Lutein

Exeltis Usa, Inc.
Human Prescription Drug
NDC 0642-0207

Strovite One Caplets also known as Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .alpha.-lipoic Acid, And Lutein is a human prescription drug labeled by 'Exeltis Usa, Inc.'. National Drug Code (NDC) number for Strovite One Caplets is 0642-0207. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Strovite One Caplets drug includes .alpha.-tocopherol Succinate, D- - 45 ug/1 Alpha Lipoic Acid - 15 mg/1 Ascorbic Acid - 300 mg/1 Biotin - 100 ug/1 Calcium Pantothenate - 7.5 mg/1 Cholecalciferol - 25 ug/1 Chromium - 50 ug/1 Cupric Sulfate - 1.5 mg/1 Cyanocobalamin - 50 ug/1 Folic Acid - 1700 ug/1 and more. The currest status of Strovite One Caplets drug is Active.

Drug Information:

Drug NDC:	0642-0207
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:	Strovite One Caplets
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Strovite One
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	Caplets
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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:	Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .alpha.-lipoic Acid, And Lutein
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:	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 SUCCINATE, D- - 45 ug/1 ALPHA LIPOIC ACID - 15 mg/1 ASCORBIC ACID - 300 mg/1 BIOTIN - 100 ug/1 CALCIUM PANTOTHENATE - 7.5 mg/1 CHOLECALCIFEROL - 25 ug/1 CHROMIUM - 50 ug/1 CUPRIC SULFATE - 1.5 mg/1 CYANOCOBALAMIN - 50 ug/1 FOLIC ACID - 1700 ug/1 Load more... LUTEIN - 5 mg/1 MAGNESIUM OXIDE - 50 mg/1 MANGANESE - 1.5 mg/1 NIACINAMIDE - 25 mg/1 PYRIDOXINE HYDROCHLORIDE - 25 mg/1 RIBOFLAVIN - 5 mg/1 SELENIUM - 100 ug/1 THIAMINE - 20 mg/1 VITAMIN A - 900 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:	04 May, 2001
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.
UPC:	0306420207907
UPC stands for Universal Product Code.
NUI:	N0000193618 M0001797 M0022797 N0000175952 N0000185508 N0000175629 N0000184306 M0000728 M0022794 N0000175951 M0022788 N0000175950
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	LU4B53JYVE 73Y7P0K73Y PQ6CK8PD0R 6SO6U10H04 568ET80C3D 1C6V77QF41 0R0008Q3JB LRX7AJ16DT P6YC3EG204 935E97BOY8 Load more... X72A60C9MT 3A3U0GI71G 42Z2K6ZL8P 25X51I8RD4 68Y4CF58BV TLM2976OFR H6241UJ22B X66NSO3N35 81G40H8B0T 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] Standardized Chemical Allergen [EPC] Vitamin B12 [EPC] Vitamin A [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 PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Ascorbic Acid [CS] Vitamin D [CS] Allergens [CS] Vitamin B 12 [CS] Vitamin A [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:	Allergens [CS] Analogs/Derivatives [Chemical/Ingredient] Ascorbic Acid [CS] Calculi Dissolution Agent [EPC] Cell-mediated Immunity [PE] Increased Histamine Release [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] Osmotic Activity [MoA] Osmotic Laxative [EPC] Standardized Chemical Allergen [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
0642-0207-03	1 BLISTER PACK in 1 BOX (0642-0207-03) / 3 TABLET in 1 BLISTER PACK	04 May, 2001	N/A	No
0642-0207-90	90 TABLET in 1 BOTTLE (0642-0207-90)	04 May, 2001	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

Strovite One Caplets

Vitamin A & more..

Tablet
Exeltis USA, Inc.
NDC: 0642-0207

Product Elements:

Strovite one caplets vitamin a, calcium pantothenate, ascorbic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, biotin, cyanocobalamin, selenium, magnesium oxide, zinc oxide, cupric sulfate, manganese, chromium, .alpha.-lipoic acid, and lutein manganese manganese croscarmellose sodium microcrystalline cellulose silicon dioxide titanium dioxide gelatin, unspecified magnesium stearate polyvinyl alcohol, unspecified starch, corn soybean oil talc sucrose ethylcellulose, unspecified polyethylene glycol, unspecified anhydrous dibasic calcium phosphate ascorbyl palmitate tocopherol sodium ascorbate medium-chain triglycerides .alpha.-tocopherol, dl- vitamin a vitamin a calcium pantothenate pantothenic acid calcium cation ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol succinate, d- .alpha.-tocopherol, d- thiamine thiamine ion riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid biotin biotin cyanocobalamin cyanocobalamin selenium selenium magnesium oxide magnesium cation zinc oxide zinc oxide cupric sulfate cupric cation chromium chromium alpha lipoic acid alpha lipoic acid lutein lutein ev0207

Drug Interactions:

Drug interactions high doses of folic acid may result in decreased serum levels of anticonvulsant drugs. vitamin d supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hyper-calcemia 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. consult appropriate references for additional specific vitamin-drug interactions.

Indications and Usage:

Indications and usage strovite Â® one is indicated to provide nutritional supplementation to support optimum vitamin and mineral levels.

Warnings and Cautions:

Warning/precautions 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. 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 above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin b12 deficiency. avoid overdosage. keep out of the reach of children.

Dosage and Administration:

Dosage and administration one caplet daily or as directed by a physician.

Contraindications:

Contraindications strovite Â® one is contraindicated in patients with hypersensitivity to any of its components. folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. 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 levels substantially higher than those in strovite Â® one.

Drug Interactions:

Pediatric Use:

Pediatric use not recommended for pediatric use.

Description:

Composition each caplet contains: vitamin a (as beta carotene) 900 mcg rae vitamin c 300 mg vitamin d (as cholecalciferol) 25 mcg vitamin e (as d-alpha tocopheryl succinate) 67 mg thiamin (as thiamine hydrochloride) 20 mg riboflavin (vitamin b2) 5 mg niacin (as niacinamide) 25 mg ne vitamin b6 (as pyridoxine hydrochloride) 25 mg folate (as folic acid) 1,670 mcg dfe vitamin b12 (as cyanocobalamin) 50 mcg biotin 100 mcg pantothenic acid (as calcium-d-pantothenate) 15 mg magnesium (as magnesium oxide) 50 mg zinc (as zinc oxide) 25 mg selenium (as sodium selenate) 100 mcg copper (as cupric sulfate) 1.5 mg manganese (as manganese sulfate) 1.5 mg chromium (as chromium chloride) 50 mcg alpha lipoic acid 7.5 mg lutein 5 mg other ingredients: microcrystalline cellulose, dicalcium phosphate, hydroxypropyl methylcellulose, croscarmellose sodium, polyethylene glycol, titanium dioxide, talc, maltodextrin, modified food starch, sucrose, polyvinyl alcohol, stearic acid, silica, magnesium stearate, corn oil, starch, vitamin e alcohol, sodium ascorbate, mannitol.

How Supplied:

How supplied strovite Â® one is a white, oblong caplet, debossed ev0207; available in bottles of 90 caplets (0642-0207-90) and as professional samples (0642-0207-03). storage conditions: store at room temperature 15Â°-30Â°c (59Â°-86Â°f). avoid excessive heat and moisture.

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 breastfeeding.

Package Label Principal Display Panel:

Principal display panel - 90 caplet bottle label 0642-0207-90 strovite Â® one iron free multivitamin and mineral supplement gluten and lactose free 90 caplets rx strovite one bottle label

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.