Label: TRICARE PRENATAL DHA ONE- multivitamin/mineral capsule, gelatin coated

  • 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 August 17, 2010

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  • Description:

    Each purple softgel contains:

    Essential Fatty Acids
    Fish Oil Concentrate 10/50 TG
    500 mg
         DHA
    215 mg
         EPA
    45 mg
    Vitamins
    Vitamin B-1 (Thiamine Nitrate)
    3 mg
    Vitamin B-2 (Riboflavin)
    3.4 mg
    Vitamin B-3 (Inositol Nicotinate)
    20 mg
    Vitamin B-6 (Pyridoxine Hydrochloride)
    25 mg
    Vitamin B-12 (Cyanocobalamin)
    100 mcg
    Folic Acid
    1 mg
    Vitamin C (Ascorbic Acid)
    60 mg
    Vitamin D3 (Cholecalciferol)
    800 IU
    Vitamin E (d-alpha-Tocopherol)
    30 IU
    Biotin
    300 mcg
    Minerals
    Iron (Ferrous Fumarate)
    27 mg
    Zinc (Zinc Sulfate Monohydrate)
    10 mg
    Copper (Cupric Sulfate Anhydrous)
    2 mg
    Docusate Sodium
    25 mg
  • INACTIVE INGREDIENTS:

    Gelatin, Glycerol, Hydrogenated Vegetable Oil, Purified Water, Yellow Beeswax, Lecithin, Colloidal Anhydrous Silica, Ethanol, Natural Lime Oil Ordinary 479208/ARTG 1258, Cochineal C175470, Lemon Oil, Titanium Dioxide, Polysorbate 80, Brilliant Blue FCF C142090

  • INDICATIONS AND USAGE:

    TriCare® Prenatal DHA ONE® Multivitamin/Mineral softgels are indicated to provide multivitamin/mineral/essential fatty acid supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother.  It is also useful for improving nutritional status prior to conception.

  • CONTRAINDICATIONS:

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • BOXED WARNING (What is this?)

    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.

  • GENERAL PRECAUTIONS

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.

  • PRECAUTIONS:

    Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

  • ADVERSE REACTIONS:

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

  • DOSAGE AND ADMINISTRATION:

    One softgel daily or as directed by a physician.

  • HOW SUPPLIED:

    TriCare® Prenatal DHA ONE® Multivitamin/Mineral Softgels for oral administration are supplied as purple softgels, imprinted in gray ink: TriCare DHA 401 in a child-resistant plastic bottle of 90 softgels. (NDC 67112-401-90).

  • BOXED WARNING (What is this?)

    WARNING:

    Ingestion of more than 3 grams of Omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR).  Administration of omega-3 fatty acids should be avoided in patients taking aniticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

  • STORAGE AND HANDLING

    NOTICE:  Contact with moisture may produce surface discoloration or erosion of the softgel.

    Store at controlled room temperature of:  20o-25oC (68o-77oF).

    Excursions permitted to 15o-30oC (59o-86oF).

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    Marketed by Medecor Pharma LLC, Baton Rouge, LA

  • PRINCIPAL DISPLAY PANEL



    TriCare Prenatal DHA ONE Label

    TriCare® Prenatal

    DHA ONE®

    Multivitamin/Mineral

    Softgel

    ESSENTIAL NUTRITION FOR THE THREE

    VITAL STAGES OF PREGNANCY

    • Preconception
    • Pregnancy
    • Postnatal
    NDC 67112-401-90

    Rx Only
  • INGREDIENTS AND APPEARANCE
    TRICARE PRENATAL DHA ONE 
    multivitamin/mineral capsule, gelatin coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67112-401
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F) FISH OIL500 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT215 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT45 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    INOSITOL NIACINATE (UNII: A99MK953KZ) (INOSITOL NIACINATE - UNII:A99MK953KZ) INOSITOL NIACINATE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN100 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL800 [iU]
    ALPHA-TOCOPHEROL, D- (UNII: N9PR3490H9) (ALPHA-TOCOPHEROL, D- - UNII:N9PR3490H9) ALPHA-TOCOPHEROL, D-30 [iU]
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
    FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7) FERROUS FUMARATE27 mg
    ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE MONOHYDRATE10 mg
    CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC SULFATE ANHYDROUS2 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALCOHOL (UNII: 3K9958V90M)  
    LIME OIL (UNII: UZH29XGA8G)  
    COCHINEAL (UNII: TZ8Z31B35M)  
    LEMON OIL (UNII: I9GRO824LL)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code TriCare;DHA;401
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67112-401-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/13/2010
    Labeler - Medecor Pharma, LLC (830621046)
    Registrant - Medecor Pharma, LLC (830621046)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalent Australia PTY LTD753617638manufacture