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VemaVite-PRx 2 (TRIGEN Laboratories, Inc.)

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CAPSULE 30 CAPSULE in 1 BOTTLE (13811-598-30) Label Information

Complete VemaVite-PRx 2 Information

  • 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 THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.


  • SPL UNCLASSIFIED SECTION

    Rx Only

    • 1.25 mg Folic Acid and 300 mg DHA (key omega-3 fatty acid)
    • Essential vitamins and minerals
    • Gentle stool softener

  • DESCRIPTION

    VemaViteâ„¢-PRx 2 is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish-based DHA. Each softgel capsule is an oblong, maroon softgel capsule imprinted with "T598" in white ink.

    Each softgel capsule contains:
    *
    • Derived from at least 338.1 mg omega-3s from at least 476.1 mg purified fish oil.
    Vitamin C (ascorbic acid, USP) 28 mg  
    Calcium (tribasic calcium phosphate, NF) 160 mg  
    Iron (ferrous fumarate, USP) 27 mg  
    Vitamin D3 (cholecalciferol, USP) 400 IU  
    Vitamin E (d-alpha tocopherol, USP) 30 IU  
    Vitamin B6 (pyridoxine hydrochloride, USP) 25 mg  
    Folic Acid, USP 1.25 mg  
    DHA (docosahexaenoic acid, contained in the oil derived from fish) 300 mg*
    Docusate Sodium, USP 55 mg  

    Inactive Ingredients: FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, Natural Creamy Orange Flavor, Gelatin, Glycerin, Lecithin, Purified Water, Soybean Oil, Titanium Dioxide, Ethyl Vanillin, Yellow Beeswax.


  • INDICATIONS

    VemaViteâ„¢-PRx 2 softgel capsules are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. VemaViteâ„¢-PRx 2 may be useful in improving the nutritional status of women prior to conception.


  • CONTRAINDICATIONS

    VemaViteâ„¢-PRx 2 is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.


  • SPL UNCLASSIFIED SECTION

    THIS PRODUCT CONTAINS FISH OIL AND SOY.


  • 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 anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.


  • PRECAUTION

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.


  • ADVERSE REACTIONS

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


  • CAUTION

    Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.


  • DOSAGE AND ADMINISTRATION

    Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.


  • HOW SUPPLIED

    Bottles of 30 softgel capsules.

    NDC 13811-598-30

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

    Store at Controlled Room Temperature 20°-25°C (68°-77°F). [See USP].


  • SPL UNCLASSIFIED SECTION

    Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

    All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

    Rx Only

    Manufactured for:
    TRIGEN Laboratories, Inc., Sayreville, NJ 08872
    www.trigenlab.com

    MADE IN CANADA

    Rev. 10/10


  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    NDC 13811-598-30
    Rx Only

    VemaViteâ„¢-PRx 2
    Softgel Capsule

    30 CAPSULES

    TRIGEN
    LABORATORIES

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

  • INGREDIENTS AND APPEARANCE
    VEMAVITE-PRX 2   WITH FISH-BASED DHA
    ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13811-598
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 28 mg
    Tribasic Calcium Phosphate (UNII: 91D9GV0Z28) (Calcium Cation - UNII:2M83C4R6ZB) Tribasic Calcium Phosphate 160 mg
    Ferrous Fumarate (UNII: R5L488RY0Q) (Iron - UNII:E1UOL152H7) Ferrous Fumarate 27 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU]
    Alpha-Tocopherol (UNII: H4N855PNZ1) (Alpha-Tocopherol - UNII:H4N855PNZ1) Alpha-Tocopherol 30 [iU]
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 25 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1.25 mg
    Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent 300 mg
    Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium 55 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Soybean Oil (UNII: 241ATL177A)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ethyl Vanillin (UNII: YC9ST449YJ)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Product Characteristics
    Color RED (maroon) Score no score
    Shape CAPSULE (oblong) Size 25mm
    Flavor ORANGE (Creamy Orange) Imprint Code T598
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13811-598-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 10/05/2011
    Labeler - TRIGEN Laboratories, Inc. (830479668)