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 kit

  • 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 26, 2019

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
    Niacinamide20 mg
    Vitamin B 6 (pyridoxine HCl) 50 mg
    Folic acid1 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

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

    Ferrazone ® is a registered trademark of AkzoNobel b v

    827582 v1 Rev. 08/2017

  • PRINCIPAL DISPLAY PANEL

    carton.jpg

  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:44118-750
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44118-750-301 in 1 CARTON; Type 0: Not a Combination Product10/30/2012
    2NDC:44118-750-051 in 1 CARTON; Type 0: Not a Combination Product10/30/2012
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 30 
    Part 21 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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE215 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON25 mg
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
    SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70) SODIUM SELENATE65 ug
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1.8 mg
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE210 ug
    CHOLINE (UNII: N91BDP6H0X) (CHOLINE - UNII:N91BDP6H0X) CHOLINE55 mg
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE2800 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL640 [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 MONONITRATE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN2 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    Product Characteristics
    Colorred (MAROON) Scoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code 750
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44118-751-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/30/2012
    Part 2 of 2
    DUET DHA BALANCED 
    omega-3 fatty acids capsule, gelatin coated
    Product Information
    Item Code (Source)NDC:44118-752
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS267 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44118-752-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/30/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/30/2012
    Labeler - Eckson Labs, LLC (078435242)