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

  • NDC Code(s): 66213-543-60
  • Packager: PBM Pharmaceuticals, Inc
  • 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 February 6, 2013

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  • Package Insert

    Animi-3®
    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

    U.S. Patent No. 8,075,910; 8,173,160
    Rx Only

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  • Description

    Animi-3® 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).

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  • Indication

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

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  • CONTRAINDICATIONS

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

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  • 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.

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  • 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.

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  • Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

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  • 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.

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  • Adverse Reactions

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

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  • Dosage and Administration

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

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  • How Supplied

    Animi-3® supplied as orange opaque oblong capsules. Each capsule in imprinted with “Animi-3” in black opacode. Animi-3® Capsules are available in bottles of 60 capsules (NDC 66213-543-60).

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  • 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.

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  • Storage Conditions:

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

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  • SPL UNCLASSIFIED SECTION

    PBM Pharmaceuticals, Inc.
    Charlottesville, VA 22902
    Rev. 0113
    ©2013 All Rights Reserved.

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  • PRINCIPAL DISPLAY PANEL

    NDC 66213-543-60 60 Capsules

    Animi-3®

    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

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  • INGREDIENTS AND APPEARANCE
    ANIMI-3 
    folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent, phytosterols capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66213-543
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 1000 [iU]
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 12.5 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 500 ug
    Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids 500 mg
    Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent 250 mg
    Icosapent (UNII: AAN7QOV9EA) (Icosapent - UNII:AAN7QOV9EA) Icosapent 35 mg
    Soy Sterol (UNII: PL360EPO9J) (Soy Sterol - UNII:PL360EPO9J) Soy Sterol 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color orange Score no score
    Shape OVAL (Capsule) Size 20mm
    Flavor Imprint Code Animi;3
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66213-543-60 60 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/01/2011
    Labeler - PBM Pharmaceuticals, Inc (785470050)
    Establishment
    Name Address ID/FEI Business Operations
    International Vitamin Corporation 964464114 manufacture(66213-543)
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