{"active_ingredient":["Active Ingredients Bismuth Subsalicylate 525 mg"],"dosage_and_administration":["Directions drink plenty of clear fluids to help prevent dehydration cause by diarrhea shake well before use adults and children 12 years of age and over: 2 tablespoonfuls (30 mL) every 1/2 hour or 4 tablespoonfuls (60 mL) every hour as needed for diarrhea/traveler's diarrhea 2 tablespoonfuls (30 mL) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablesproonfuls or 240 mL) in 24 hours use until diarrhea stops but not more than 2 days Children under 12 years: ask a doctor"],"effective_time":"20250722","id":"3a8b33c7-04b9-345d-e063-6294a90abba9","inactive_ingredient":["Inactive ingredients benzoic acid, citric acid, FD&C yellow #5, flavor, salicylic acid, sodium citrate, sodium salicylate, sorbic acid, sucralose, water, xanthan gum"],"indications_and_usage":["Uses relieves traveler's diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M024"],"brand_name":["Bismutina"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["Menper Distributors, Inc."],"nui":["M0002611","N0000180183"],"package_ndc":["53145-475-08"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["53145-475"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308762"],"spl_id":["3a8b33c7-04b9-345d-e063-6294a90abba9"],"spl_set_id":["14bbbdbb-87c8-47a9-9147-7e0f1b75c7b9"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0042279501086"]},"package_label_principal_display_panel":["bismutina"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Upset Stomach Reliever and Antidiarrheal"],"questions":["Questions? call 1-800-560-5223 M-F 9 AM to 5 PM Eastern Time"],"set_id":"14bbbdbb-87c8-47a9-9147-7e0f1b75c7b9","spl_product_data_elements":["Bismutina Bismuth subsalicylate BENZOIC ACID ANHYDROUS CITRIC ACID FD&C YELLOW NO. 5 SALICYLIC ACID SODIUM CITRATE SODIUM SALICYLATE SORBIC ACID SUCRALOSE WATER XANTHAN GUM BISMUTH SUBSALICYLATE SALICYLIC ACID"],"version":"3","warnings":["Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because there symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have an ulcer a bleeding problem bloody or black stool Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis When using this product, a temporary, but harmless, darking of the stool and/or tongue may occur. Stop use and ask a doctor if symptoms get worse or last for more than two days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days"]}