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

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.

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BP Vit 3 Capsules
Rx Only

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.

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

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

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
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)  
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
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)

Revised: 10/2023
Document Id: 5c66f0de-f322-4042-b46f-84dfeacd21cb
Set id: 8bf7a233-1813-4989-8886-fe7257a16054
Version: 5
Effective Time: 20231011
 
Acella Pharmaceuticals, LLC