{"active_ingredient":["Active ingredient (in each tablet) Bismuth subgallate 200 mg"],"dosage_and_administration":["Directions Adults and children 12 years and over: 1 to 2 tablets up to four times daily. Do not exceed 8 tablets in 24 hours. Children under 12 years: ask a doctor."],"effective_time":"20241112","id":"61d82c84-289a-4d83-a8ed-6c026f9edec9","inactive_ingredient":["Inactive ingredients magnesium stearate, microcrystalline cellulose, natural banana flavor. starch, talc, xylitol."],"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":["49309-001-01"],"product_ndc":["49309-001"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308757","1942846"],"spl_id":["61d82c84-289a-4d83-a8ed-6c026f9edec9"],"spl_set_id":["6a9408b1-9085-42e6-9104-c6986d5446a9"],"substance_name":["BISMUTH SUBGALLATE"],"unii":["YIW503MI7V"],"upc":["0866344000300"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label Devrom ® (200 mg bismuth subgallate) Internal Deodarant 100 chewable tablets PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label"],"purpose":["Purpose Internal Deodorant"],"questions":["Questions? 1-800-453-8898"],"set_id":"6a9408b1-9085-42e6-9104-c6986d5446a9","spl_product_data_elements":["Devrom bismuth subgallate BISMUTH SUBGALLATE BISMUTH CATION MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN TALC XYLITOL D"],"spl_unclassified_section":["Drug Facts","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.","distributed by The Parthenon Company, Inc."],"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."]}