Nestabs Dha Prenatal Multi-vitamin/mineral Supplement With Dha/epa
Sodium Ascorbate, Cholecalciferol, Di-alpha-tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hcl, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous (ii) Bis-glycinate Chelate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, With Doconexent And Icosapent
Womens Choice Pharmaceuticals Llc
Human Prescription Drug
NDC 50967-317Nestabs Dha Prenatal Multi-vitamin/mineral Supplement With Dha/epa also known as Sodium Ascorbate, Cholecalciferol, Di-alpha-tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hcl, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous (ii) Bis-glycinate Chelate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, With Doconexent And Icosapent is a human prescription drug labeled by 'Womens Choice Pharmaceuticals Llc'. National Drug Code (NDC) number for Nestabs Dha Prenatal Multi-vitamin/mineral Supplement With Dha/epa is 50967-317. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Nestabs Dha Prenatal Multi-vitamin/mineral Supplement With Dha/epa drug includes . The currest status of Nestabs Dha Prenatal Multi-vitamin/mineral Supplement With Dha/epa drug is Active.
Drug Information:
| Drug NDC: | 50967-317 |
| 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 Dha Prenatal Multi-vitamin/mineral Supplement With Dha/epa |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Nestabs Dha |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA |
| 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: | Sodium Ascorbate, Cholecalciferol, Di-alpha-tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hcl, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous (ii) Bis-glycinate Chelate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, With Doconexent And Icosapent |
| 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: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 01 Feb, 2011 |
| 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: | 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: | 0350967317308
|
| UPC stands for Universal Product Code. |
| UNII: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50967-317-30 | 4 BLISTER PACK in 1 CARTON (50967-317-30) / 1 KIT in 1 BLISTER PACK | 01 Feb, 2011 | 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:
Nestabs dha prenatal multi-vitamin/mineral supplement with dha/epa sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent nestabs multi-vitamin/mineral supplement sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate thiamine mononitrate thiamine ion thiamine ion riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin calcium formate calcium cation calcium carbonate calcium cation ferrous bisglycinate ferrous cation cellulose, microcrystalline magnesium stearate povidone polyvinyl alcohol titanium dioxide talc fd&c red no. 40 aluminum oxide saccharin sodium ascorbate ascorbic acid cholecalciferol cholecalciferol alpha-tocopherylquinone alpha-tocopherylquinone potassium iodide iodide ion zinc oxide zinc oxide choline bitartrate choline wc;001 nestabs omega 3-dha doconexent and icosapent supplement gelatin glycerin water doconexent doconexent icosapent icosapent .alpha.-tocopherol, d- .alpha.-tocopherol, d- ;
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 the reach of children. in case of accidental overdose, call a doctor or poison control center immediately.
Indications and Usage:
I ndications and usage: nestabs dha is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal for both lactating and nonlactating mothers. nestabs dha is also beneficial in improving the nutritional status of women prior to conception.
Warnings:
W arnings: ingestion of more than 3 grams of omega-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:
D osage and administration: nestabs dha - one tablet and one soft gel capsule daily or as directed by a physician.
Contraindications:
C ontraindications: this product is contraindicated in patients with a known hypersensitivity to any of the ingredients .
Adverse Reactions:
A dverse reactions: allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Description:
D escripton: nestabs dha combination tablet-capsule for oral administration is a light pink capsule-shaped film coated tablet with a pleasant sweet flavor with wcoo1 imprinted on one side of the tablet and a enteric coated light amber soft gel capsule omega-3 fatty acid containing both dha and epa.
How Supplied:
H ow supplied: nestabs dha tablets for oral administration are supplied as six child-resistant blister cards containing 5 tablets and 5 softgel capsules each (ndc# 50967-317-30).
Package Label Principal Display Panel:
Label