{"dosage_and_administration":["Dosage and Administration Adults: One to four softgels as directed by a physician."],"effective_time":"20260619","health_claim":["Contraindications This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.","Pediatric Use Safety and effectivess in pediatric patients have not been established.","Pregnancy and Lactation The safety of phytosterols has not been studied in pregnant or breastfeeding women. There is no evidence that dietary intakes of naturally occuring phytosterols, such as those consumed by vegetarian women, adversely affect pregnancy or laction.","Adverse Reactions Allergic sensitization has been reported following oral, enteral and parenteral administration of folic acid.","How Supplied BP Vit 3 Capsules are supplied as red, opaque, oblong, imprinted softgel capsules. Each softgel 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.","Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 1-800-541-4802 L-0146 Rev. 0920-01"],"id":"549ea33b-9475-9597-e063-6294a90a644f","openfda":{"brand_name":["BP Vit 3"],"generic_name":["FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL"],"is_original_packager":[true],"manufacturer_name":["Acella Pharmaceuticals, LLC"],"nui":["M0022794","N0000175951","M0023885","N0000175583"],"package_ndc":["42192-301-60"],"pharm_class_cs":["Vitamin B 12 [CS]","Fatty Acids, Omega-3 [CS]"],"pharm_class_epc":["Vitamin B12 [EPC]","Omega-3 Fatty Acid [EPC]"],"product_ndc":["42192-301"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["549ea33b-9475-9597-e063-6294a90a644f"],"spl_set_id":["8bf7a233-1813-4989-8886-fe7257a16054"],"substance_name":["FOLIC ACID","PYRIDOXINE HYDROCHLORIDE","CYANOCOBALAMIN","OMEGA-3 FATTY ACIDS","DOCONEXENT","ICOSAPENT",".BETA.-SITOSTEROL"],"unii":["935E97BOY8","68Y4CF58BV","P6YC3EG204","71M78END5S","ZAD9OKH9JC","AAN7QOV9EA","S347WMO6M4"]},"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 BP Vit3 Capsules Bottle Label"],"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.] Dispense in a well-closed, tight, light-resistant container as defined by the USP using a child resistant closure."],"set_id":"8bf7a233-1813-4989-8886-fe7257a16054","spl_product_data_elements":["BP Vit 3 folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and .beta.-sitosterol GELATIN GLYCERIN BEESWAX WATER LECITHIN, SOYBEAN TITANIUM DIOXIDE FD&C RED NO. 40 ASCORBIC ACID ASCORBYL PALMITATE TOCOPHEROL 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 red opaque BP;301"],"statement_of_identity":["Supplement Facts Other Ingredients: Ascorbyl palmitate, beeswax, mixed tocopherols and soy lecithin. Capsule (bovine gelatin, FD&C Red No. 40, glycerin, purified water, and titanium dioxide). Contains soy. BP Vit3 Capsules Supplement Facts Panel","Indications BP Vit 3 Capsules are indicated for improving nutritional status in conditions requiring essential fatty acid, vitamin B 12 and B 6 and folic acid supplementation as well as for patients where cholesterol levels are a concern."],"version":"7","warnings":["Warning Keep this and all medications out of the reach of children."]}