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: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 19, 2026

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  • Supplement Facts

    BP Vit3 Capsules Supplement Facts Panel

    Other Ingredients: Ascorbyl palmitate, beeswax, mixed tocopherols and soy lecithin. Capsule (bovine gelatin, FD&C Red No. 40, glycerin, purified water, and titanium dioxide).

    Contains soy.

  • Indications

    BP Vit 3 Capsules are indicated for improving nutritional status in conditions requiring essential fatty acid, vitamin B 12 and B 6 and folic acid supplementation as well as for patients where cholesterol levels are a concern.

  • Contraindications

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • 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.

  • Pediatric Use

    Safety and effectivess 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 occuring phytosterols, such as those consumed by vegetarian women, adversely affect pregnancy or laction.

  • Adverse Reactions

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

  • Warning

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

  • Dosage and Administration

    Adults: One to four softgels as directed by a physician.

  • How Supplied

    BP Vit 3 Capsules are supplied as red, opaque, oblong, imprinted softgel capsules. Each softgel 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.

  • Storage

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

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

  • HEALTH CLAIM

    Manufactured for:

    Acella Pharmaceuticals, LLC

    Alpharetta, GA 30005

    1-800-541-4802

    L-0146 Rev. 0920-01

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

    42192-301-60

    BP Vit 3 Capsules

    Rx Only 60 Capsules

    Acella
    PHARMACUETICALS, LLC

    BP Vit3 Capsules Bottle Label

  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: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)  
    BEESWAX (UNII: 2ZA36H0S2V)  
    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)  
    Product Characteristics
    Colorred (red opaque) Scoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code BP;301
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-301-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/17/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/17/2009
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Registrant - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939manufacture(42192-301)
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