Duet Dha 400
.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iodine, Omega-3 Fatty Acids
Eckson Labs, Llc
Human Prescription Drug
NDC 44118-807Duet Dha 400 also known as .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iodine, Omega-3 Fatty Acids is a human prescription drug labeled by 'Eckson Labs, Llc'. National Drug Code (NDC) number for Duet Dha 400 is 44118-807. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Duet Dha 400 drug includes . The currest status of Duet Dha 400 drug is Active.
Drug Information:
| Drug NDC: | 44118-807 |
| 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: | Duet Dha 400 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Duet Dha |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | 400 |
| 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: | .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iodine, Omega-3 Fatty Acids |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Eckson Labs, 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: | 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: | 09 Sep, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | Eckson Labs, 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. |
| 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 |
|---|
| 44118-807-30 | 1 KIT in 1 CARTON (44118-807-30) * 30 TABLET in 1 BOTTLE (44118-803-30) * 30 CAPSULE, GELATIN COATED in 1 BOTTLE (44118-805-30) | 09 Sep, 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:
Duet dha 400 .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, iodine, omega-3 fatty acids duet .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, iodine cellulose, microcrystalline starch, corn silicon dioxide magnesium stearate polyethylene glycol, unspecified polyvinyl alcohol titanium dioxide talc fd&c red no. 40 fd&c blue no. 1 fd&c blue no. 2 .beta.-carotene .beta.-carotene ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol acetate, d- .alpha.-tocopherol, d- thiamine mononitrate thiamine ion thiamine riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin calcium carbonate calcium cation iron iron magnesium oxide magnesium cation zinc oxide zinc cation cupric oxide cupric cation iodine iodine maroon caplet 800 duet dha omega-3 fatty acids gelatin glycerin water .alpha.-tocopherol, d- ethyl vanillin omega-3 fatty acids omega-3 fatty acids
Drug Interactions:
Drug interactions: pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.
Indications and Usage:
Indications: this product is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. this product is also useful in improving the nutritional status prior to conception.
Warnings:
Warnings: folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin b 12 is deficient. since daily ingestion of more than 3 grams per day of omega-3 fatty acids, including alpha-linolenic acid (ala), eicosapentaenoic acid (epa) and docosahexaenoic acid (dha), from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of dha should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. keep out of reach of children.
Dosage and Administration:
Dosage and administration: before, during and after pregnancy, one tablet and one softgel capsule taken by mouth daily or as directed by a physician. the tablet and softgel capsule may be taken together or at different times of the day. caution should be exercised to ensure that the prescribed dose of dha does not exceed 1 gram (1,000 mg) per day.
Contraindications:
Contraindications: this product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil.
Adverse Reactions:
Adverse reactions: allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Drug Interactions:
Drug interactions: pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.
Description:
Description: this product is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral and omega-3 fatty acids, supplied as tablets and softgel capsules. each tablet contains: supplement facts serving size: 1 tablet amount per serving vitamin a (beta carotene) 2,800 iu vitamin c (ascorbic acid) 120 mg vitamin d (cholecalciferol) 820 iu vitamin e (dl-alpha tocopheryl acetate) 3 mg vitamin b 1 (thiamine mononitrate) 1.8 mg vitamin b 2 (riboflavin) 4 mg niacinamide 20 mg vitamin b 6 (pyridoxine hydrochloride) 50 mg folic acid 1 mg vitamin b 12 (cyanocobalamin) 12 mcg calcium (calcium carbonate) 200 mg iron (polysaccharide iron complex and sodium iron (iii) ethylenediaminetetraacetate, ferrazone ® ) 25 mg magnesium (magnesium oxide) 25 mg zinc (zinc oxide) 25 mg copper (cupric oxide) 2 mg iodine 220 mcg other ingredients: microcrystalline cellulose, starch, silica, magnesium stearate, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, fd&c red no. 40 aluminum lake, fd&c blue no. 1 & no. 2 aluminum lake 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. each softgel capsule contains in a clear solution of 400 mg purified omega-3 long-chain fatty acids including dha (docosahexaenoic acid) and epa (eicosapentaenoic acid). supplement facts serving size: 1 softgel capsule amount per serving total omega-3 long-chain fatty acids (as dha and epa) 400 mg other ingredients: gelatin, glycerin, purified water
How Supplied:
How supplied: a 30-day regimen supplied in a carton, ndc 44118-807-30, consisting of one bottle containing 30 maroon tablets, imprinted â800â, and one bottle containing 30 softgel capsules. these child-resistant bottles are tamper evident by foil seal under cap.
Package Label Principal Display Panel:
Carton.jpg