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

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated December 31, 2019

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  • 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.

  • 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.

  • DOSAGE & ADMINISTRATION

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

    SUPPLEMENT FACTS
    Each Capsule Contains
    Folic Acid1 mg
    Vitamin B612.5 mg
    Vitamin B12500 mcg
    Omega-3 Acids500 mg
    -DHA350 mg
    -EPA35 mg
    Phytosterols200 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.

  • 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.

  • 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.]

  • 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.

  • 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
  • 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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:42192-301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    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) DOCONEXENT350 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT35 mg
    .BETA.-SITOSTEROL (UNII: S347WMO6M4) (.BETA.-SITOSTEROL - UNII:S347WMO6M4) .BETA.-SITOSTEROL200 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:42192-301-6060 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/17/2009
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)25 mm
    imprint
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939manufacture(42192-301)