DuetDHA Balanced

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

Rx Only

DESCRIPTION:

This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega 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 D3 (cholecalciferol)  640 IU
Vitamin E (d-alpha tocopheryl acetate)   15 mg
Vitamin B1 (thiamine mononitrate)   1.5 mg
Vitamin B2 (riboflavin)   2 mg
Niacinamide   20 mg
Vitamin B6 (pyridoxine HCl)   50 mg
Folic acid   1 mg
Vitamin B12 (cyanocobalamin)   12 mcg
Calcium (calcium carbonate)   215 mg
Iron (polysaccharide iron complex and sodium iron (III) ethylenediaminetetraacetate, Ferrazone®)  25 mg
Magnesium (magnesium stearate)   25 mg
Zinc (zinc oxide)   25 mg
Selenium (sodium selenate)   65 mcg
Copper (cupric oxide)  1.8 mg
Iodine (potassium iodide) 210 mcg
Choline (choline bitartrate)   55 mg

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 267 mg purified omega long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid), DPA (docosapentaenoic acid) and ALA (alpha-linolenic acid):

Supplement Facts
Serving Size: 1 Softgel Capsule
 Amount Per Serving
Total omega-3 long-chain fatty acids (as DHA, EPA, DPA, and ALA) 267 mg

Other ingredients: gelatin, rice bran oil, glycerin, purified water

INDICATIONS:

This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega 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 ALA (alpha-linolenic acid), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), 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 44118-750-30, containing 6 child-resistant blister cards. Each blister card contains 5 maroon Duet® tablets (imprinted “750”) and 5 softgel capsules. Tamper evident by foil seal.

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

v1 Rev. 07/2013

DUET DHA BALANCED 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium, zinc oxide, sodium selenate, cupric oxide, iodine, choline, omega-3 fatty acids kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44118-750
Packaging
# Item Code Package Description
1 NDC:44118-750-30 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BLISTER PACK 30 
Part 2 1 BLISTER PACK 30 
Part 1 of 2
DUET DHA BALANCED 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium, zinc oxide, sodium selenate, cupric oxide, iodine, choline tablet
Product Information
Item Code (Source) NDC:44118-751    
Route of Administration oral DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (.BETA.-CAROTENE) BETA CAROTENE 2800 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 640 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 15 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 2 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 215 mg
IRON (IRON) IRON 25 mg
MAGNESIUM (MAGNESIUM) MAGNESIUM 25 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
SODIUM SELENATE (SELENATE ION) SODIUM SELENATE 65 ug
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 1.8 mg
IODINE (IODINE) IODINE 210 ug
CHOLINE (CHOLINE) CHOLINE 55 mg
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 Size 21mm
Flavor Imprint Code 750
Contains         
Packaging
# Item Code Package Description
1 NDC:44118-751-30 30 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/30/2012
Part 2 of 2
DUET DHA BALANCED 
omega-3 fatty acids capsule, gelatin coated
Product Information
Item Code (Source) NDC:44118-752    
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 267 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
RICE BRAN OIL  
GLYCERIN  
WATER  
Product Characteristics
Color yellow Score no score
Shape capsule Size 21mm
Flavor Imprint Code NONE
Contains         
Packaging
# Item Code Package Description
1 NDC:44118-752-30 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/30/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/30/2012
Labeler - Eckson Labs, LLC (078435242)
Revised: 10/2014
 
Eckson Labs, LLC



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