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
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 October 11, 2023
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- STATEMENT OF IDENTITY
- WARNINGS
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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.
- PRECAUTIONS
- SAFE HANDLING WARNING
- HEALTH CLAIM
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 60 capsule container image
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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, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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) Product Characteristics Color RED (red opaque) Score no score Shape CAPSULE Size 25mm Flavor Imprint Code BP;301 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42192-301-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/17/2009 Labeler - Acella Pharmaceuticals, LLC (825380939) Registrant - Acella Pharmaceuticals, LLC (825380939) Establishment Name Address ID/FEI Business Operations Acella Pharmaceuticals, LLC 825380939 manufacture(42192-301)