NDC 44118-807 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

NDC Product Code 44118-807

NDC CODE: 44118-807

Proprietary Name: Duet Dha 400 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

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 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 44118 - Eckson Labs, Llc

NDC 44118-807-30

Package Description: 1 KIT in 1 CARTON * 30 TABLET in 1 BOTTLE (44118-803-30) * 30 CAPSULE, GELATIN COATED in 1 BOTTLE (44118-805-30)

NDC Product Information

Duet Dha 400 with NDC 44118-807 is a a human prescription drug product labeled by Eckson Labs, Llc. The generic name of Duet Dha 400 is .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. The product's dosage form is kit and is administered via oral form.

Labeler Name: Eckson Labs, Llc

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TALC (UNII: 7SEV7J4R1U)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
  • ETHYL VANILLIN (UNII: YC9ST449YJ)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Eckson Labs, Llc
Labeler Code: 44118
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-09-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Duet Dha 400 Product Label Images

Duet Dha 400 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 ServingVitamin A (beta carotene)2,800 IUVitamin C (ascorbic acid)120 mgVitamin D (cholecalciferol)820 IUVitamin E (dl-alpha tocopheryl acetate)3 mgVitamin B
1 (thiamine mononitrate)
1.8 mgVitamin B
2 (riboflavin)
4 mgNiacinamide20 mgVitamin B
6 (pyridoxine hydrochloride)
50 mgFolic acid1 mgVitamin B
12 (cyanocobalamin)
12 mcgCalcium (calcium carbonate)200 mgIron (polysaccharide iron complex and sodium iron (III) ethylenediaminetetraacetate, Ferrazone
®)
25 mgMagnesium (magnesium oxide)25 mgZinc (zinc oxide)25 mgCopper (cupric oxide)2 mgIodine220 mcgOTHER 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 ServingTotal omega-3 long-chain fatty acids (as DHA and EPA)400 mgOTHER INGREDIENTS: gelatin, glycerin, purified water

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.

Contraindications:

This product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil.

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.

Precautions:

Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive).

Drug Interactions:

Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.

Adverse Reactions:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

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.

How Supplied:

A 30-day regimen supplied in a carton, NDC 44118-807-30, consisting of one bottle containing 30 maroon tablets, imprinted “800”, and one bottle containing 30 softgel capsules. These child-resistant bottles are tamper evident by foil seal under cap.

Storage:

Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Relative humidity not to exceed 65%. Protect from moisture, excessive heat and freezing. Note that contact with moisture may produce surface discoloration of the tablet.To report a serious adverse event or obtain product information, call 1-855-899-4237.
www.DuetDHA.comManufactured for:

Eckson Labs, LLC

1000 N. West St., Suite 1200, #927

Wilmington, DE 19801
Ferrazone® is a registered trademark of AkzoNobel b vv5 Rev. 10/2017

* Please review the disclaimer below.