FDA Label for Bp Vit 3

View Indications, Usage & Precautions

Bp Vit 3 Product Label

The following document was submitted to the FDA by the labeler of this product Acella Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 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



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


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