Label: 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

  • NDC Code(s): 44118-750-05, 44118-750-30, 44118-751-30, 44118-752-30
  • Packager: Eckson Labs, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated December 20, 2017

If you are a consumer or patient please visit this version.

  • 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 D 3 (cholecalciferol) 640 IU
    Vitamin E (dl-alpha tocopheryl acetate) 15 mg
    Vitamin B 1 (thiamine mononitrate) 1.5 mg
    Vitamin B 2 (riboflavin) 2 mg
    Niacinamide 20 mg
    Vitamin B 6 (pyridoxine HCl) 50 mg
    Folic acid 1 mg
    Vitamin B 12 (cyanocobalamin) 12 mcg
    Calcium (calcium carbonate) 215 mg
    Iron (polysaccharide iron complex and sodium iron (III) ethylenediaminetetraacetate, Ferrazone ®) 25 mg
    Magnesium (magnesium oxide) 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 long-chain fatty acids (as DHA, EPA, DPA and ALA) 267 mg

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

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  • 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.

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  • CONTRAINDICATIONS:

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

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  • 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.

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  • 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).

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  • DRUG INTERACTIONS:

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

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  • ADVERSE REACTIONS:

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

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  • 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.

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  • 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.

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  • 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:
    1000 N. West St., Suite 1200, #927
    Wilmington, DE 19801

    Ferrazone ® is a registered trademark of AkzoNobel b v

    827582 v1 Rev. 08/2017

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  • INGREDIENTS AND APPEARANCE
    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 Item Code (Source) NDC:44118-750
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44118-750-30 1 in 1 CARTON; Type 0: Not a Combination Product 10/30/2012
    2 NDC:44118-750-05 1 in 1 CARTON; Type 0: Not a Combination Product 10/30/2012
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 50 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 215 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 25 mg
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM 25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg
    SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70) SODIUM SELENATE 65 ug
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1.8 mg
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 210 ug
    CHOLINE (UNII: N91BDP6H0X) (CHOLINE - UNII:N91BDP6H0X) CHOLINE 55 mg
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 2800 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 640 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 15 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE 1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 2 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    Product Characteristics
    Color red (MAROON) Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code 750
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44118-751-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 267 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color yellow Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code NONE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44118-752-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
    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)
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