{"active_ingredient":["Drug Facts Active ingredient (in each 30 mL) Bismuth subsalicylate 525 mg Purpose Upset stomach reliever and antidiarrheal"],"ask_doctor":["Ask a doctor before use if you have ▪ fever ▪ mucus in stool"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking any drug for ▪ anticoagulation (thinning of the blood) ▪ diabetes ▪ gout ▪ arthritis"],"do_not_use":["Do not use if you have ▪ an ulcer ▪ a bleeding problem ▪ black or bloody stool"],"dosage_and_administration":["Directions ▪ shake well before use ▪ use dose cup or tablespoon (TBSP) ▪ adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed ▪ do not exceed 8 doses (240 mL or 16 TBSP) 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":"20260324","id":"4dc9233e-68fc-e1e8-e063-6294a90aee33","inactive_ingredient":["Inactive ingredients benzoic acid, D&C red #22, D&C red # 28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum"],"indications_and_usage":["Uses relieves: ▪ diarrhea ▪ heart burn ▪ indigestion ▪ nausea ▪ upset stomach associated with these symptoms"],"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":["Dr. Simi Stomach Relief"],"generic_name":["BISMUTH SUBSALICYLATE 525 MG"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"nui":["M0002611","N0000180183"],"package_ndc":["85786-802-12"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["85786-802"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308762"],"spl_id":["4dc9233e-68fc-e1e8-e063-6294a90aee33"],"spl_set_id":["4dc9233e-68fb-e1e8-e063-6294a90aee33"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0199961000218"]},"other_safety_information":["Other information ▪ each 30 mL dose cup contains: sodium 13 mg, salicylate 256 mg ▪ protect from freezing avoid excessive heat (over 104°F or 40C) ▪ low sodium"],"package_label_principal_display_panel":["Immediate container labeling Label"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask health professional before use."],"purpose":["Purpose Upset stomach reliever and antidiarrheal"],"questions":["Questions or comments? (855)-280-1079"],"set_id":"4dc9233e-68fb-e1e8-e063-6294a90aee33","spl_product_data_elements":["Dr. Simi Stomach Relief BISMUTH SUBSALICYLATE 525 MG BENZOIC ACID XANTHAN GUM D&C RED NO. 22 D&C RED NO. 28 WATER SACCHARIN SODIUM ANHYDROUS SALICYLIC ACID BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID SODIUM SALICYLATE"],"spl_unclassified_section":["Principal Display Panel NDC 85786-802-12 DR. SIMI Regular Strength Stomach Relief Bismuth Subsalicylate 525 mg Antidiarrheal /Upset Stomach Reliever Relieves: ▪ Upset Stomach ▪ Nausea ▪ Heartburn ▪ Indigestion ▪ Diarrhea 12 fl oz (354 mL) TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken *Compare to the active ingredient in PEPTO-BISMOL™ *This product is not manufactured or distributed by Procter&Gamble the distributor of Pepto-Bismol ® Distributed by: FARMACIAS DE SIMILARES TX LLC. 800 Brazos St Ste 260, Austin, TX, 78701, USA customerservice@drsimi.com www.drsimi.com"],"stop_use":["Stop use and ask a doctor if ▪ diarrhea lasts more than 2 days ▪ symptoms get worse or last more than 2 days ▪ ringing in the ears or loss of hearing occurs"],"version":"1","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 Do not use if you have ▪ an ulcer ▪ a bleeding problem ▪ black or bloody stool Ask a doctor before use if you have ▪ fever ▪ mucus in stool Ask a doctor or pharmacist before use if you are taking any drug for ▪ anticoagulation (thinning of 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 ▪ diarrhea lasts more than 2 days ▪ symptoms get worse or last more than 2 days ▪ ringing in the ears or loss of hearing occurs If pregnant or breast feeding, ask health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur"]}