{"active_ingredient":["Active ingredient (in each 30 mL dose) 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 shake well before use Only use dose cup provided adults and children 12 years and over: (30 mL) 1 dose every 1/2 or 60 mL every hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (240 mL) 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":"20251110","id":"433b7a06-ddb7-da11-e063-6294a90a65ae","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum"],"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 at (1-800-222-1222)."],"openfda":{"application_number":["M008"],"brand_name":["TopCare Regular Strength"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["TOPCO ASSOCIATES LLC"],"nui":["M0002611","N0000180183"],"package_ndc":["36800-661-16","36800-661-08"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["36800-661"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308762"],"spl_id":["433b7a06-ddb7-da11-e063-6294a90a65ae"],"spl_set_id":["2619720a-d926-4b17-899c-54d49c78802c"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0036800133174","0036800133167"]},"package_label_principal_display_panel":["Principal Display Panel TopCare ® health ™ *Compare to the Active Ingredient Pepto-Bismol® Regular Strength REGULAR STRENGTH Pink Bismuth Bismuth Subsalicylate 525 mg per 30 mL Upset Stomach Reliever/Antidiarrheal Relieves: Nausea Heartburn Indigestion Upset Stomach Diarrhea Cherry Flavor Naturally and Artificially Flavored DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 TOPCO RARA1217 QUESTIONS? 1-888-423-0139 topcare@topco.com , www.topcarebrand.com *This product is not manufactured or distributed by Procter & Gamble, distributor Pepto-Bismol ® Regular Strength. Package Label 473 mL Topcare Regular Strength Pink Bismuth 473 mL Package Label 236 mL Topcare Regular Strength Pink Bismuth Cherry Flavor 236 mL"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Upset stomach reliever and antidiarrheal"],"questions":["Questions or comments? 1-866-467-2748 DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN."],"set_id":"2619720a-d926-4b17-899c-54d49c78802c","spl_product_data_elements":["TopCare Regular Strength Bismuth subsalicylate CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C RED NO. 22 D&C RED NO. 28 MICROCRYSTALLINE CELLULOSE POTASSIUM HYDROXIDE POTASSIUM SORBATE WATER SALICYLIC ACID DIMETHICONE, UNSPECIFIED SODIUM BENZOATE SUCRALOSE XANTHAN GUM BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID viscous"],"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 30 mL contains: sodium 10 mg salicylate 261 mg low sodium sugar free store at room temperature protect from freezing avoid excessive heat (over 104°F or 40°C)"],"version":"7","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 or 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 right away at (1-800-222-1222)."],"when_using":["When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur"]}