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

BP Vit 3 by

Drug Labeling and Warnings

BP Vit 3 by is a Prescription medication manufactured, distributed, or labeled by Acella Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

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

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		04/17/2009

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)

Establishment
Name	Address	ID/FEI	Business Operations
Acella Pharmaceuticals, LLC		825380939	manufacture(42192-301)