Label: BP VIT 3 - folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and .beta.-sitosterol capsule, coated

  • NDC Code(s): 42192-301-60
  • Packager: Acella Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated September 25, 2014

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    STATEMENT OF IDENTITY: BP Vit 3 is a prescription improving nutritional status in conditions requiring Essential Fatty Acid, Vitamin B12 and B6 and Folic Acid supplementation capsule. Each capsule is imprinted with “BP 301” on one side.

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  • WARNINGS

    WARNING: Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

    Keep this and all medications out of the reach of children.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Adults: One to four capsules as directed by a physician.

    SUPPLEMENT FACTS
    Each Capsule Contains
    Folic Acid 1 mg
    Vitamin B6 12.5 mg
    Vitamin B12 500 mcg
    Omega-3 Acids 500 mg
    -DHA 350 mg
    -EPA 35 mg
    Phytosterols 200 mg

    How Supplied: BP Vit 3 Capsules are supplied as red, opaque, oblong, imprinted capsules. Each capsule is imprinted with “BP 301” on one side. BP Vit 3 capsules are available in bottles of 60 (42192-301-60).

    The listed product number is not a National Drug Code, but has merely been formatted to comply with industry practice standard for pharmacy and insurance computer systems.

    OTHER INGREDIENTS: bovine gelatin, glycerin, white beeswax, purified water, soy lecithin, titanium dioxide, FD&C Red #40, ascorbic acid, ascorbyl palmitate and mixed tocopherols.

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  • PRECAUTIONS

    PRECAUTIONS: Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

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  • SAFE HANDLING WARNING

    STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

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  • HEALTH CLAIM

    HEALTH CLAIMS: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 60 capsule container image

    42192-301-60

    BP Vit 3 Capsules

    Rx Only           60 Capsules

    Acella
    PHARMACUETICALS, LLC

    PRINCIPAL DISPLAY PANEL - 60 Capsles
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  • INGREDIENTS AND APPEARANCE
    BP VIT 3  
    folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and .beta.-sitosterol capsule, coated
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:42192-301
    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
    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 350 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 35 mg
    .BETA.-SITOSTEROL (UNII: S347WMO6M4) (.BETA.-SITOSTEROL - UNII:S347WMO6M4) .BETA.-SITOSTEROL 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:42192-301-60 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 02/27/2008
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    scoring 1
    shape
    size (solid drugs) 25 mm
    imprint
    Labeler - Acella Pharmaceuticals, LLC (825380939)
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