Skip to Content

Duet DHA 400

Generic Name: prenatal multi-vitamin, multi-mineral and omega-3 fatty acids
Dosage Form: tablets/softgel capsules

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Duet DHA 400 ec

Rx Only

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) 2,825 IU
Vitamin C (ascorbic acid) 120 mg
Vitamin D (cholecalciferol) 800 IU
Vitamin E (d-alpha tocopheryl acetate) 3 mg
Vitamin B1 (thiamine mononitrate) 1.8 mg
Vitamin B2 (riboflavin) 4 mg
Niacinamide 20 mg
Vitamin B6 (pyridoxine hydrochloride) 45 mg
Folic acid 1 mg
Vitamin B12 (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, surelease dispersion, d-alpha tocopherol, ethyl vanillin

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 B12 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 44118-809-30, 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.com

Manufactured for:
Eckson Labs, LLC
1000 N. West St., Suite 1200, #927
Wilmington, DE 19801

Ferrazone® is a registered trademark of AkzoNobel b v

DUET DHA  400 EC
.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 kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44118-809
Packaging
# Item Code Package Description
1 NDC:44118-809-30 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30 
Part 2 1 BOTTLE 30 
Part 1 of 2
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 tablet
Product Information
Item Code (Source) NDC:44118-804    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2825 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 800 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 3 mg
THIAMINE MONONITRATE (THIAMINE ION) Thiamine 1.8 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 45 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
IRON (IRON) IRON 25 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
IODINE (IODINE) IODINE 220 ug
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
TITANIUM DIOXIDE  
TALC  
FD&C RED NO. 40  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
Product Characteristics
Color red (maroon) Score no score
Shape capsule (caplet) Size 20mm
Flavor Imprint Code 800
Contains         
Packaging
# Item Code Package Description
1 NDC:44118-804-30 30 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/09/2011
Part 2 of 2
DUET DHA 
omega-3 fatty acids capsule, gelatin coated
Product Information
Item Code (Source) 44118-805    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 400 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
WATER  
.ALPHA.-TOCOPHEROL ACETATE, D-  
ETHYL VANILLIN  
Product Characteristics
Color yellow Score no score
Shape capsule Size 16mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 44118-805-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 09/09/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/09/2011
Labeler - Eckson Labs, LLC (078435242)
Registrant - Stayma Consulting Services, LLC (969000517)
Revised: 03/2014
 
Eckson Labs, LLC



Hide