DUET DHA 400 (.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALA

DUET DHA 400 (.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALA
PDF | XML

NDC 44118-803-30, 44118-805-30, 44118-807-30
Set ID 9532f8de-115c-4f37-9148-2e6899800f65
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Eckson Labs, LLC
Generic Name
Product Class
Product Number
Application Number
  • 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)2,800 IU
    Vitamin C (ascorbic acid)120 mg
    Vitamin D (cholecalciferol)820 IU
    Vitamin E (dl-alpha tocopheryl acetate)3 mg
    Vitamin B 1 (thiamine mononitrate) 1.8 mg
    Vitamin B 2 (riboflavin) 4 mg
    Niacinamide20 mg
    Vitamin B 6 (pyridoxine hydrochloride) 50 mg
    Folic acid1 mg
    Vitamin B 12 (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
    Iodine220 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

  • 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 B 12 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 44118-807-30, 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

    1800009 v1 Rev. 07/2018

  • PRINCIPAL DISPLAY PANEL

    carton.jpg

  • INGREDIENTS AND APPEARANCE
    DUET DHA  400
    .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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:44118-807
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44118-807-301 in 1 CARTON; Type 0: Not a Combination Product09/09/2011
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 30 
    Part 21 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:44118-803
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .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) CHOLECALCIFEROL820 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-3 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.8 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    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 CATION200 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON25 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE220 ug
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Colorred (maroon) Scoreno score
    ShapeCAPSULE (caplet) Size20mm
    FlavorImprint Code 800
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44118-803-3030 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/09/2011
    Part 2 of 2
    DUET DHA 
    omega-3 fatty acids capsule, gelatin coated
    Product Information
    Item Code (Source)NDC:44118-805
    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 ACIDS400 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44118-805-3030 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/09/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/09/2011
    Labeler - Eckson Labs, LLC (078435242)