{"active_ingredient":["Active ingredient (in each softgel) Bismuth subsalicylate 262 mg"],"ask_doctor":["Ask a doctor before use if you have fever mucus in the stool"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis"],"do_not_use":["Do not use if you have an ulcer a bleeding problem bloody or black stool"],"dosage_and_administration":["Directions swallow with water, do not chew adults and children 12 years and over: 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 16 softgels in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea"],"effective_time":"20260127","id":"495a7b34-57db-3f94-e063-6394a90ad088","inactive_ingredient":["Inactive ingredients"],"indications_and_usage":["Uses relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M008"],"brand_name":["Bismuth subsalicylate"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["Softgel Healthcare Pvt Ltd"],"nui":["M0002611","N0000180183"],"package_ndc":["35916-0234-1"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["35916-0234"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2121072"],"spl_id":["495a7b34-57db-3f94-e063-6394a90ad088"],"spl_set_id":["18f59606-1498-bd0c-e063-6394a90a7df2"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0335916023417"]},"other_safety_information":["Other information each softgel contains: salicylate 102 mg low sodium do not exceed 25°C"],"package_label_principal_display_panel":["Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use"],"purpose":["Purpose Upset stomach reliever and antidiarrheal"],"set_id":"18f59606-1498-bd0c-e063-6394a90a7df2","spl_product_data_elements":["Bismuth subsalicylate Bismuth subsalicylate WATER POLYSORBATE 20 SORBITOL TITANIUM DIOXIDE D&C RED NO. 33 BISMUTH SUBSALICYLATE SALICYLIC ACID GLYCERIN POLYETHYLENE GLYCOL 400 GELATIN POVIDONE oblong Opaque"],"stop_use":["Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days"],"version":"2","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 these symptoms could be an early sign 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"],"when_using":["When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur"]}