{"active_ingredient":["Active ingredient (in each caplet) Bismuth subsalicylate 525 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: 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (8 caplets) 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":"20251009","id":"40be321b-5e7e-14b6-e063-6294a90ab11f","inactive_ingredient":["Inactive ingredients calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate"],"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."],"openfda":{"application_number":["M008"],"brand_name":["Pepto-Bismol ULTRA"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["Procter & Gamble Manufactura, S. de R.L. de C.V."],"nui":["M0002611","N0000180183"],"package_ndc":["58933-478-24","58933-478-12"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["58933-478"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1998447","1998449"],"spl_id":["40be321b-5e7e-14b6-e063-6294a90ab11f"],"spl_set_id":["63283ebc-cff8-07d4-e053-2a91aa0a9de0"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0301490001288"]},"overdosage":["In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 12 Caplet Carton Pepto Bismol® ULTRA Bismuth Subsalicylate Upset Stomach Reliever/ Antidiarrheal 2x CONCENTRATED FORMULA* 5 SYMPTOM RELIEF NAUSEA HEARTBURN INDIGESTION UPSET STOMACH DIARRHEA 12 CAPLETS 478"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use."],"purpose":["Purpose Upset stomach reliever and antidiarrheal"],"questions":["Questions? 1-800-717-3786"],"set_id":"63283ebc-cff8-07d4-e053-2a91aa0a9de0","spl_product_data_elements":["Pepto-Bismol ULTRA Bismuth subsalicylate MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 CALCIUM CARBONATE POVIDONE D&C RED NO. 27 SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE BISMUTH SUBSALICYLATE SALICYLIC ACID Caplet Pepto"],"spl_unclassified_section":["Drug Facts","TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.","MADE IN MEXICO DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202"],"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"],"storage_and_handling":["Other information each caplet contains: calcium 54 mg salicylate 199 mg very low sodium avoid excessive heat (over 104°F or 40°C)"],"version":"10","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 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"],"when_using":["When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur"]}