{"active_ingredient":["Active ingredient (in each tablet) 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 bloody or black stool if you have an ulcer or bleeding problem Drug Facts continued on back of label"],"dosage_and_administration":["Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea repeat dosage every 1/2 to 1 hour as needed do not take more than 8 doses in 24 hours use until diarrhea stops but not more than 2 days adults and children 12 years and over: 2 tablets children under 12 years: ask a doctor"],"effective_time":"20250115","id":"2bc8473d-ad00-da1d-e063-6394a90ae0d4","inactive_ingredient":["Inactive ingredients calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol"],"indications_and_usage":["Uses controls diarrhea relieves upset stomach due to overindulgence in food or drink"],"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 262 mg"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["Reliable 1 Laboratories LLC"],"nui":["M0002611","N0000180183"],"package_ndc":["69618-029-03"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["69618-029"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308761"],"spl_id":["2bc8473d-ad00-da1d-e063-6394a90ae0d4"],"spl_set_id":["2e40ffd8-1afa-43af-e054-00144ff8d46c"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0369618029033"]},"package_label_principal_display_panel":["NDC 69618-029-03 Bismuth Subsalicylate 262 mg UPSET STOMACH RELIEVER / ANTIDIARRHEAL 30 CHEWABLE TABLETS *compare to Active Ingredients in Pepto-Bismol® Bismuth"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Anti-diarrheal / Upset stomach reliever"],"questions":["Questions or comments? call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday"],"set_id":"2e40ffd8-1afa-43af-e054-00144ff8d46c","spl_product_data_elements":["Bismuth Subsalicylate 262 mg Bismuth Subsalicylate CALCIUM CARBONATE DEXTROSE CHERRY MAGNESIUM STEARATE MALTODEXTRIN D&C RED NO. 27 SILICON DIOXIDE BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID SORBITOL AP;045"],"spl_unclassified_section":["Drug Facts","Allergy alert: Contains salicylates. Do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products","Other information each tablet contains: calcium 77 mg, salicylate 102 mg store at 15°-30°C (59°-86°F) protect from moisture","TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING","*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Pepto-Bismol® Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580 www.reliable1labs.com"],"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":"6","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."],"when_using":["When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur"]}