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

DESCRIPTION:

Duet® DHA Balanced 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)
2,840 IU
Vitamin C (ascorbic acid)
120 mg
Vitamin D (cholecalciferol)
840 IU
Vitamin E (d-alpha tocopheryl acetate)
2 mg
Vitamin B1 (thiamine mononitrate)
1.5 mg
Vitamin B2 (riboflavin)
4 mg
Niacinamide
20 mg
Vitamin B6 (pyridoxine hydrochloride)
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®)
26 mg
Magnesium (magnesium oxide)
25 mg
Zinc (zinc oxide)
25 mg
Copper (cupric oxide)
2 mg
Iodine
210 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 278 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid), ALA (alpha-linolenic acid), and DPA (docosapentaenoic acid).
Supplement Facts
Serving Size: 1 Softgel Capsule


Amount Per Serving
Total omega-3 long-chain fatty acids (as DHA, EPA, ALA, and DPA)
278 mg
OTHER INGREDIENTS: gelatin, rice bran oil, glycerin, purified water

INDICATIONS:

Duet® DHA Balanced 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. Duet® DHA Balanced 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.

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:

Duet® DHA Balanced is a 30-day regimen supplied in a carton, NDC 44118-800-30, containing 6 child-resistant blister cards. Each blister card contains 5 maroon Duet® tablets (imprinted “800”) and 5 softgel capsules. Tamper evident by foil seal.

STORAGE: Store at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F 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.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

To request medical information or to report suspected adverse reactions, 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. 08/2012
DUET DHA BALANCED 
.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:44118-800
Packaging
# Item Code Package Description
1 NDC:44118-800-30 1 KIT (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 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:44118-801    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2480 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 840 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 2 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 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 26 mg
MAGNESIUM (MAGNESIUM) MAGNESIUM 25 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
IODINE (IODINE) IODINE 210 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 Size 21mm
Flavor Imprint Code 800
Contains         
Packaging
# Item Code Package Description
1 NDC:44118-801-30 30 TABLET (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, liquid filled
Product Information
Item Code (Source) NDC:44118-802    
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 278 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
RICE BRAN OIL  
GLYCERIN  
WATER  
Product Characteristics
Color yellow (glossy, transparent) Score no score
Shape CAPSULE (oblong) Size 21mm
Flavor Imprint Code none
Contains         
Packaging
# Item Code Package Description
1 NDC:44118-802-30 30 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 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: 03/2013
 
Eckson Labs, LLC



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