{"active_ingredient":["Active ingredient (in each 15 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: ▪ 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea ▪ 15 mL (1 dose) every ½ hour as needed overindulgence (upset stomach, heartburn, indigestion, nausea) ▪ 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 clear fluids to help prevent dehydration caused by diarrhea"],"effective_time":"20260220","id":"4b54fa21-d8ea-4497-aa32-17e47669c8e1","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, 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":["SIGNATURE CARE Ultra Strength Stomach"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["SAFEWAY"],"nui":["M0002611","N0000180183"],"package_ndc":["21130-193-12"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["21130-193"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308763"],"spl_id":["4b54fa21-d8ea-4497-aa32-17e47669c8e1"],"spl_set_id":["4b54fa21-d8ea-4497-aa32-17e47669c8e1"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0321130789642"]},"package_label_principal_display_panel":["Principal Display Panel Signature SELECT™ NDC 21130-193-12 COMPARE TO the active ingredient in Pepto-Bismol ® * STOMACH RELIEF ULTRA STRENGTH ORIGINAL FLAVOR Bismuth Subsalicylate 525 MG Upset Stomach Reliever/Antidiarrheal Relief of: ▪ Nausea, Heartburn, Indigestion, Upset Stomach, Diarrhea 12 FL. OZ. (354 mL) 2X CONCENTRATED FORMULA** Distributed by: BETTER LIVING BRANDS LLC P.O. BOX 99 PLEASANTON, CA 94566-0009 ‡1-888-723-3929 **vs Original Pepto Bismol® *This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol ® Ultra. Signature Select Ultra Strength Stomach Relief 354 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":"4b54fa21-d8ea-4497-aa32-17e47669c8e1","spl_product_data_elements":["SIGNATURE CARE Ultra Strength Stomach Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C RED NO. 22 D&C RED NO. 28 GELLAN GUM (LOW ACYL) MICROCRYSTALLINE CELLULOSE POTASSIUM HYDROXIDE POTASSIUM SORBATE WATER SALICYLIC ACID DIMETHICONE, UNSPECIFIED SODIUM BENZOATE SUCRALOSE XANTHAN GUM 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 15 mL dose cup contains: potassium 7 mg, sodium 5 mg ▪ salicylate 230 mg ▪ low sodium ▪ sugar free ▪ store at room temperature ▪ protect from freezing ▪ avoid excessive heat (over 104°F or 40°C)"],"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 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"]}