Nestabs One

Vitamin C, Vitamin D, Vitamin E, Vitamin B6, Folate, Vitamin B12, Iron, Zinc, Magnesium, Dha

Womens Choice Pharmaceuticals, Llc
Human Prescription Drug
NDC 50967-410

Nestabs One also known as Vitamin C, Vitamin D, Vitamin E, Vitamin B6, Folate, Vitamin B12, Iron, Zinc, Magnesium, Dha is a human prescription drug labeled by 'Womens Choice Pharmaceuticals, Llc'. National Drug Code (NDC) number for Nestabs One is 50967-410. This drug is available in dosage form of Capsule, Gelatin Coated. The names of the active, medicinal ingredients in Nestabs One drug includes Antazoline - 225 mg/1 Calcium Ascorbate - 18 mg/1 Cholecalciferol - 6.25 ug/1 Cyanocobalamin - 15 ug/1 Folic Acid - 1 mg/1 Iron - 38 mg/1 Magnesium Oxide - 15 mg/1 Pyridoxine Hydrochloride - 30 mg/1 Tocopherol - 10 mg/1 Zinc Oxide - 1 mg/1 . The currest status of Nestabs One drug is Active.

Drug Information:

Drug NDC:	50967-410
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:	Nestabs One
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:	Vitamin C, Vitamin D, Vitamin E, Vitamin B6, Folate, Vitamin B12, Iron, Zinc, Magnesium, Dha
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Womens Choice Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule, Gelatin Coated
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:	ANTAZOLINE - 225 mg/1 CALCIUM ASCORBATE - 18 mg/1 CHOLECALCIFEROL - 6.25 ug/1 CYANOCOBALAMIN - 15 ug/1 FOLIC ACID - 1 mg/1 IRON - 38 mg/1 MAGNESIUM OXIDE - 15 mg/1 PYRIDOXINE HYDROCHLORIDE - 30 mg/1 TOCOPHEROL - 10 mg/1 ZINC OXIDE - 1 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:	20 Jul, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 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, 2023
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:	Womens Choice Pharmaceuticals, LLC
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:	0350967410306
UPC stands for Universal Product Code.
NUI:	M0022797 N0000175952 M0022794 N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	DHA8014SS1 183E4W213W 1C6V77QF41 P6YC3EG204 935E97BOY8 E1UOL152H7 3A3U0GI71G 68Y4CF58BV R0ZB2556P8 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 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:	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
50967-410-30	30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (50967-410-30)	20 Jul, 2017	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

Nestabs One

Vitamin C & more..

Capsule, Gelatin Coated
Womens Choice Pharmaceuticals, LLC
NDC: 50967-410

Product Elements:

Nestabs one vitamin c, vitamin d, vitamin e, vitamin b6, folate, vitamin b12, iron, zinc, magnesium, dha iron iron zinc oxide zinc oxide folic acid folic acid antazoline antazoline tocopherol tocopherol docusate sodium white wax lecithin, soybean calcium ascorbate ascorbic acid cyanocobalamin cyanocobalamin magnesium oxide magnesium cation cholecalciferol cholecalciferol pyridoxine hydrochloride pyridoxine water gelatin type b bovine (160 bloom) glycerin fd&c red no. 40 titanium dioxide fd&c blue no. 1 opaque one

Boxed Warning:

Warning : accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. keep this product out of the reach of children . in case of accidental overdose, call a doctor or poison control center immediately

Indications and Usage:

Indication and usage : nestabsÂ® one is a prescription prenatal multi-vitamin/mineral supplement with dha that can be taken throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers. nestabsÂ® one may also be useful in improving the nutritional status of women prior to conception. the usual dose is one softgel daily, or as directed by a physician.

Warnings:

Warnings : ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and inr. administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis. folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin b12 is deficient.

Dosage and Administration:

Dosage and administration : one softgel taken orally each day, or as directed by a physician.

Dosage Forms and Strength:

Each nestabsÂ® one softgel contains: vitamin c (as calcium ascorbate) 18 mg vitamin d (as cholecalciferol) 6.25 mcg vitamin e (as d-alpha tocopheryl acetate) 10 mg vitamin b6 (as pyridoxine hcl) 30 mg folate (as (6s)-5 1 mg dfe* -methyltetrahydrofolate -quatrefolicÂ®) â¡ vitamin b12 (as cyanocobalamin) 15 mcg iron (as carbonyl iron and ferrous 38 mg bis-glycinate chelate -ferrochelÂ®) â¡â¡ zinc (as zinc oxide) 20 mg magnesium (as magnesium oxide) 15 mg dha (docosahexaenoic acid from algal oil) 225 mg *dietary folate equivalent (dfe)

Contraindications:

Contraindications : this product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Adverse Reactions:

Adverse reactions : allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Description:

Description: nestabsÂ® one is a prescription prenatal multi-vitamin/mineral in the form of a purple, opaque softgel capsule imprinted âoneâ for oral administration.

How Supplied:

How supplied : nestabsÂ® one softgels for oral administration are supplied in child resistant bottles containing 30 softgels, item 50967-410-30 and as professional samples, item 50967-410-03. rx to report a serious adverse event or obtain product information, contact 1-800-664-1490. distributed by: womens choice pharmaceuticals, llc berwyn, pa 19312 www.wcpharma.com nestabsÂ® is a registered trademark of womens choice pharmaceuticals, llc â¡ quatrefolicÂ® under exclusive license from gnosis, s.p.a covered by u.s. patent no. 7,947,662 and patents pending pct/ep2008/052037 and pct/ep2008/052034 â¡â¡ ferrochelÂ® is a registered trademark of albion laboratories, inc., covered by u.s. patents 6,716,814 and 7,838,042.

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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.