The following Structured Product Label (SPL) was submitted to the FDA by Acella Pharmaceuticals, Llc for the product Bp Vit 3 (NDC 42192-301). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding statement of identity, warnings, dosage & administration, precautions, safe handling warning, health claim, package label.principal display panel - 60 capsule container image, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 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: 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.
42192-301-60
BP Vit 3 Capsules
Rx Only 60 Capsules
Acella
PHARMACUETICALS, LLC
Principal Display Panel (60 Capsles)
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