{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "BP Vit 3 folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and .beta.-sitosterol FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN OMEGA-3 FATTY ACIDS OMEGA-3 FATTY ACIDS DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT .BETA.-SITOSTEROL .BETA.-SITOSTEROL GELATIN GLYCERIN WHITE WAX WATER LECITHIN, SOYBEAN TITANIUM DIOXIDE FD&C RED NO. 40 ASCORBIC ACID ASCORBYL PALMITATE TOCOPHEROL red opaque BP;301" ], "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_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 B 6 12.5 mg Vitamin B 12 500 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." ], "dosage_and_administration_table": [ "
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
" ], "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": [ "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" ], "set_id": "8bf7a233-1813-4989-8886-fe7257a16054", "id": "0c3ef3d6-cd24-4253-a3eb-4d06e3047bf7", "effective_time": "20250213", "version": "6", "openfda": { "brand_name": [ "BP Vit 3" ], "generic_name": [ "FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL" ], "manufacturer_name": [ "Acella Pharmaceuticals, LLC" ], "product_ndc": [ "42192-301" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ ".BETA.-SITOSTEROL", "CYANOCOBALAMIN", "DOCONEXENT", "FOLIC ACID", "ICOSAPENT", "OMEGA-3 FATTY ACIDS", "PYRIDOXINE HYDROCHLORIDE" ], "spl_id": [ "0c3ef3d6-cd24-4253-a3eb-4d06e3047bf7" ], "spl_set_id": [ "8bf7a233-1813-4989-8886-fe7257a16054" ], "package_ndc": [ "42192-301-60" ], "is_original_packager": [ true ], "nui": [ "M0022794", "N0000175951", "M0023885", "N0000175583" ], "pharm_class_cs": [ "Vitamin B 12 [CS]", "Fatty Acids, Omega-3 [CS]" ], "pharm_class_epc": [ "Vitamin B12 [EPC]", "Omega-3 Fatty Acid [EPC]" ], "unii": [ "S347WMO6M4", "P6YC3EG204", "ZAD9OKH9JC", "935E97BOY8", "AAN7QOV9EA", "71M78END5S", "68Y4CF58BV" ] } } ] }