Label: ANIMI-3 WITH VITAMIN D- folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent capsule

  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 23, 2011

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  • Package Insert

    Animi-3® with Vitamin D
        Each Capsule Contains:
        Folic Acid (Vitamin B9)                              1mg
        Cholecalciferol (Vitamin D3)                       1000IU
        Pyridoxine Hydrochloride (Vitamin B6)        12.5mg
        Cyanocobalamin (Vitamin B12)                   500mcg
        Omega-3 Acids                                         500mg
        -Docosahexaenoic Acid (DHA)                    350mg
        -Eicosapentaenoic Acid (EPA)                    35mg
        Phytosterols (Plant Sterols)                        200mg

    Patent Pending
    Rx Only
  • Description

    Animi-3® with Vitamin D Capsules are intended for oral administration.
    Each Capsule Contains: 1mg Vitamin B-9 (Folic Acid USP), 1000IU Vitamin D-3 (Cholecalciferol), 12.5mg Vitamin B-6 (Pyridoxine Hydrochloride, USP), 500mcg vitamin B-12 (Cyanocobalamin, USP), Pharmaceutical Grade omega-3 Fish Oil providing 500mg Omega-3 Acids; including 350mg Docosahexaenoic Acid (DHA) and 35mg Eicosapentaenoic Acid (EPA) and 200mg Plant Sterols (Phytosterols).
    Also Contains: Bleached Lecithin NF, Ascorbic Acid USP, Mixed Tocopherols NF, Ascorbyl Palmitate NF and a soft shell capsule (which contains; Gelatin USP, Glycerin NF, Titanium Dioxide USP, FD and C Red #40, FD and C Yellow #6 and USP Purified Water).

  • Indication

    Animi-3® with Vitamin D Capsules are indicated for improving nutritional status in conditions requiring Essential Fatty Acids, Vitamin B12, Vitamin B6, Vitamin D3 and Folic Acid supplementation.


    This product is contraindicated in patients with a known hyper-sensitivity to any of the ingredients.

  • Warning

    Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anti-coagulants and in those known to have inherited or acquired bleeding diathesis.

  • Warning

    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 1.0mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

  • Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

  • Pregnancy and Lactation

    The safety of phytosterols has not been studied in pregnant or breastfeeding women. There is no evidence that dietary intakes of naturally occurring phytosterols, such as those consumed by vegetarian women, adversely affects pregnancy or lactation.

  • Adverse Reactions

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

  • Dosage and Administration

    Adults – One capsule per day or as directed by a physician.

  • How Supplied

    Animi-3® with Vitamin D supplied as orange opaque oblong capsules. Each capsule in imprinted with “Animi-3D” in black opacode. Animi-3® with Vitamin D Capsules are available in bottles of 60 capsules (NDC 66213-542-60).

  • Keep out of reach of children.

    Dispense in a well-closed, tight light-resistant container as defined in the USP using a child-resistant closure.

  • Storage Conditions:

    Store at 20-25°C (68-77°F). See USP Controlled Room Temperature. Protect from light and moisture.


    PBM Pharmaceuticals, Inc.
    Charlottesville, VA 22902
    Rev. 0411
    ©2011 All Rights Reserved.


    NDC  66213-542-60     60 Capsules

    Animi 3D with Vitamin D

    Folic Acid (Vitamin B-9)         1 mg
    Cholecalciferol (Vitamin D-3)     1000 IU
    Pyridoxine Hydrochloride (Vitamin B-6)     12.5 mg
    Cyanocobalamin (Vitamin B-12)     500 mcg
    Omega 3 Acids      500 mg
    – Docosahexaenoic Acid (DHA)    350 mg
    – Eicosapentaenoic Acid (EPA)    35 mg
    Phytosterols (Plant Sterols)    200 mg

    Rx Only

    Image of label

    folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66213-542
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol1000 [iU]
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride12.5 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin500 ug
    Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids500 mg
    Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent250 mg
    Icosapent (UNII: AAN7QOV9EA) (Icosapent - UNII:AAN7QOV9EA) Icosapent35 mg
    Soy Sterol (UNII: PL360EPO9J) (Soy Sterol - UNII:PL360EPO9J) Soy Sterol200 mg
    Inactive Ingredients
    Ingredient NameStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Water (UNII: 059QF0KO0R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVAL (Capsule) Size20mm
    FlavorImprint Code Animi;3D
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66213-542-6060 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2011
    Labeler - PBM Pharmaceuticals, Inc (785470050)
    NameAddressID/FEIBusiness Operations
    International Vitamin Corporation964464114manufacture