{"active_ingredient":["ACTIVE INGREDIENT(in each 15 mL) 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 of the blood) diabetes gout arthritis"],"do_not_use":["DO NOT USE IF YOU HAVE an ulcer bloody or black stool a bleeding problem"],"dosage_and_administration":["DIRECTIONS shake well before use mL = milliliter TBSP = tablespoon adults and children 12 years and over: 1 dose (2 TBSP or 15 mL) every 1/2 hour as needed do not exceed 8 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration caused by diarrhea"],"effective_time":"20250103","id":"ac8d100b-47c0-483e-bec7-289e54cb7337","inactive_ingredient":["INACTIVE INGREDIENTS benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum."],"indications_and_usage":["USE(S) relieves: diarrhea heartburn 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 immediately."],"openfda":{"application_number":["M008"],"brand_name":["Quality Choice Stomach Relief 528"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["Chain Drug Marketing Association Inc."],"nui":["M0002611","N0000180183"],"package_ndc":["83324-021-08"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["83324-021"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308763"],"spl_id":["ac8d100b-47c0-483e-bec7-289e54cb7337"],"spl_set_id":["e065320d-09ee-4ab8-868a-ab3b4239e392"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 83324-021-08 QUALITY CHOICE *compare to the active ingredient in Pepto-Bismol ® Ultra Ultra Strength Stomach Relief Upset Stomach Reliever/Anti-diarrheal bismuth subsalicylate 525 mg per 15 mL Relieves: Diarrhea Heartburn Indigestion Nausea & Upset Stomach Original Flavor 8 FL OZ (236 mL) 528-qch"],"pregnancy_or_breast_feeding":["IF PREGNANT OR BREAST-FEEDING, ask a health professional before use."],"purpose":["PURPOSE Upset stomach reliever and anti-diarrheal"],"set_id":"e065320d-09ee-4ab8-868a-ab3b4239e392","spl_product_data_elements":["Quality Choice Stomach Relief 528 Bismuth subsalicylate BISMUTH SUBSALICYLATE SALICYLIC ACID BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 POTASSIUM HYDROXIDE WATER SACCHARIN SODIUM SALICYLIC ACID HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) DIMETHICONE XANTHAN GUM"],"stop_use":["STOP USE AND ASK DOCTOR IF symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days"],"storage_and_handling":["OTHER INFORMATION each 15 mL or 1 TBSP contains: potassium 15 mg salicylate 236 mg sodium 5 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C) dosage cup provided"],"version":"2","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"]}