{"adverse_reactions":["Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"contraindications":["Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["Description: BP FoliNatal Plus B Tablets is a prescription multivitamin/mineral nutritional supplement containing controlled-release vitamin B6. Each oval-shaped, blue, film-coated tablet for oral administration contains: Vitamins: Vitamin B6 (pyridoxine hydrochloride, USP) 75 mg Folic Acid, USP 1 mg Vitamin B12 (cyanocobalamin) 12 mcg Minerals: Calcium (calcium carbonate) 200 mg"],"dosage_and_administration":["Dosage and Administration: Usual dosage is one tablet daily, or as prescribed by a physician.","KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein."],"effective_time":"20180424","geriatric_use":["Geriatric Use: Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"how_supplied":["How Supplied: BP FoliNatal Plus B Tablets are oval-shaped, blue, film-coated tablets, packaged in bottles of 30 tablets (NDC 42192-324-30). Store at controlled room temperature 15 - 30°C (59 - 86°F)."],"id":"6a9c62c6-56b2-775e-e053-2991aa0ac922","inactive_ingredient":["Inactive Ingredients: Maltodextrin, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Hypromellose, Polyvinyl Alcohol-Part, Titanium Dioxide, Talc, Macrogol, Indigo Carmine, Lecithin, Brilliant Blue, Allura Red, Tartrazine."],"indications_and_usage":["Indications: BP FoliNatal Plus B Tablets are indicated to provide vitamin and mineral supplementation prior to and during pregnancy and may be used in conjunction with a physician-prescribed regimen to minimize pregnancy-related nausea."],"openfda":{},"package_label_principal_display_panel":["Package Labeling: Label7 Label6"],"precautions":["Precautions: Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"set_id":"6a9c55a3-bbe7-1eb9-e053-2a91aa0a3e54","spl_product_data_elements":["BP Folinatal Plus B PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM MALTODEXTRIN CROSCARMELLOSE SODIUM STEARIC ACID MAGNESIUM STEARATE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TITANIUM DIOXIDE TALC POLYETHYLENE GLYCOL, UNSPECIFIED INDIGOTINDISULFONATE SODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 5 PYRIDOXINE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CALCIUM 324"],"spl_unclassified_section":["BP FoliNatal Plus B Tablets Rx Only","MANUFACTURED FOR: Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802"],"version":"1","warnings":["Warning: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses about 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive."]}