{"active_ingredient":["Active ingredient (in each capsule) Bismuth subgallate 200 mg"],"dosage_and_administration":["Directions Adults and children 12 years and over: 1 to 2 capsules up to four times daily or as directed by physician. Do not exceed 8 capsules in 24 hours. Children under 12 years: ask a doctor."],"effective_time":"20241112","id":"6d691cdb-1787-413c-84fc-5f030db289f9","inactive_ingredient":["Inactive ingredients microcrystalline cellulose, maltodextrine, croscarmellose, silica, magnesium stearate."],"indications_and_usage":["Use for eliminating or reducing odor from flatulence (gas) and stool (feces)."],"keep_out_of_reach_of_children":["Keep out of reach of children ."],"openfda":{"application_number":["M026"],"brand_name":["Devrom"],"generic_name":["BISMUTH SUBGALLATE"],"is_original_packager":[true],"manufacturer_name":["The Parthenon Co., Inc."],"package_ndc":["49309-002-01"],"product_ndc":["49309-002"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["283720","2106743"],"spl_id":["6d691cdb-1787-413c-84fc-5f030db289f9"],"spl_set_id":["fb6ad16b-caac-4a63-a10e-99808a6a83e7"],"substance_name":["BISMUTH SUBGALLATE"],"unii":["YIW503MI7V"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label Devrom ® (200 mg bismuth subgallate) Internal Deodorant 100 capsules PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. In case of overdose, get medical help or contact a Poison Control Center right away."],"purpose":["Purpose Internal Deodorant"],"questions":["Questions? 1-800-453-8898"],"set_id":"fb6ad16b-caac-4a63-a10e-99808a6a83e7","spl_product_data_elements":["Devrom bismuth subgallate BISMUTH SUBGALLATE BISMUTH CATION MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE MALTODEXTRIN CROSCARMELLOSE SODIUM SILICON DIOXIDE CLEAR Devrom"],"spl_unclassified_section":["Drug Facts","Manufactured for and distributed by The Parthenon Company, Inc."],"storage_and_handling":["Other Information This product cannot be expected to be effective in the reduction of odor due to faulty personal hygiene. Does not contain gluten, lactose, or salicylates. Store in a cool, dry place. Do not use if outer safety seal or printed inner safety seal is broken."],"version":"3","warnings":["Warnings If pregnant or breast-feeding , ask a health professional before use. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children ."]}