{"active_ingredient":["Drug Facts Active ingredient (in each caplet) 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 caplets with water, do not chew adults and children 12 years and over : 2 caplets (1 dose) every 1/2 hour or 4 caplets (2 doses) every hour as needed for diarrhea 2 caplets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 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":"20250211","id":"2de450b8-01e2-0e3b-e063-6394a90af5f7","inactive_ingredient":["croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin."],"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":["Bismuth Subsalicylate"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["LEADER/ Cardinal Health 110, Inc."],"nui":["M0002611","N0000180183"],"package_ndc":["70000-0594-1"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["70000-0594"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308760"],"spl_id":["2de450b8-01e2-0e3b-e063-6394a90af5f7"],"spl_set_id":["d4af6694-910c-da17-e053-2995a90a8454"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0096295141375"]},"other_safety_information":["Other information each caplet contains : salicylate 102 mg Store in a dry place at 15° – 30°C (59° – 86°F) TAMPER EVIDENT : do not use if printed seal under cap is torn or missing"],"overdosage":["In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."],"package_label_principal_display_panel":["Leader Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Upset stomach reliever and antidiarrheal"],"questions":["Questions or comments? 1-800-231-4670"],"set_id":"d4af6694-910c-da17-e053-2995a90a8454","spl_product_data_elements":["Bismuth Subsalicylate Bismuth Subsalicylate CROSPOVIDONE MICROCRYSTALLINE CELLULOSE TALC BISMUTH SUBSALICYLATE SALICYLIC ACID SODIUM LAURYL SULFATE SILICON DIOXIDE TITANIUM DIOXIDE HYPROMELLOSES CROSCARMELLOSE SODIUM TRIACETIN LIGHT MINERAL OIL POVIDONE K30 STEARIC ACID MAGNESIUM STEARATE V"],"spl_unclassified_section":["RETAIN THIS CARTON FOR FULL LABELING INFORMATION WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov. COMPARE TO PEPTO-BISMOL active ingredient* *This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 Product of Mexico"],"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":"3","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. 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 darkening of the stool and/or tongue may occur. 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."],"when_using":["When using this product a temporary but harmless darkening of the stool and/or tongue may occur."]}