bp vit 3 capsules

bp vit 3 capsules
SPL v6
SPL
SPL Set ID 8bf7a233-1813-4989-8886-fe7257a16054
Route
oral
Published
Effective Date 2023-10-11
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
folic acid (1 mg) pyridoxine (12.5 mg) cyanocobalamin (500 ug) omega-3 fatty acids (500 mg) doconexent (350 mg) icosapent (35 mg) .beta.-sitosterol (200 mg)
Inactive Ingredients
gelatin glycerin white wax water lecithin, soybean titanium dioxide fd&c red no. 40 ascorbic acid ascorbyl palmitate tocopherol

Identifiers & Packaging

Pill Appearance
Imprint: BP;301 Shape: capsule Color: red Size: 25 mm Score: 1
Marketing Status
unapproved drug other active Since 2009-04-17

Description

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.


Medication Information

Warnings and Precautions

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

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.

Description

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.

Section 42232-9

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.

Section 50741-8

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

Section 69718-5

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.

Section 69719-3

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


Structured Label Content

Warnings and Precautions (34071-1)

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 (34068-7)

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.

Section 42232-9 (42232-9)

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.

Section 50741-8 (50741-8)

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

Section 69718-5 (69718-5)

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.

Section 69719-3 (69719-3)

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 (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 60 capsule container image)

42192-301-60

BP Vit 3 Capsules

Rx Only           60 Capsules

Acella

PHARMACUETICALS, LLC


Advanced Ingredient Data


Raw Label Data

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