{"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 diabetes gout arthritis anticoagulation (thinning the blood)"],"do_not_use":["Do not use if you have an ulcer a bleeding problem bloody or black stool"],"dosage_and_administration":["Directions do not take more than 8 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration caused by diarrhea mL = milliliter shake well before using measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product adults and children 12 years and over: 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed diarrhea/traveler's diarrhea 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) children under 12 years of age: ask a doctor"],"effective_time":"20240829","id":"97eae925-c64a-4ef6-bc32-eaa88b1a64d3","inactive_ingredient":["Inactive ingredients benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, 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 fullness belching"],"keep_out_of_reach_of_children":["Keep out of reach of childen. In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M008"],"brand_name":["Stomach Relief Ultra"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories, Inc."],"nui":["M0002611","N0000180183"],"package_ndc":["0536-1287-36"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["0536-1287"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308763"],"spl_id":["97eae925-c64a-4ef6-bc32-eaa88b1a64d3"],"spl_set_id":["87394088-1d2e-4ca4-bbfe-1481c9d4a3ba"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0305361287368"]},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredient in Pepto-Bismol ® Ultra* extra strength Stomach relief bismuth subsalicylate 525 mg per 15 mL upset stomach reliever/antidiarrheal relieves: heartburn indigestion nausea upset stomach diarrhea 2x strength per ounce † alcohol free sugar free fl oz (mL) *This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol ® is a registered trademark of The Procter & Gamble Company. † vs Original Pepto-Bismol ® TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. Distributed by: RUGBY ® LABORATORIES, Indianapolis, IN 46268","Package Label Rugby - Extra Strength Stomach Relief Bismuth Subsalicylate 525 mg per 15 mL"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Upset stomach reliever/Antidiarrheal"],"questions":["Questions or comments? Call 1-800-645-2158"],"set_id":"87394088-1d2e-4ca4-bbfe-1481c9d4a3ba","spl_product_data_elements":["Stomach Relief Ultra Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 GLYCERIN WATER SUCRALOSE XANTHAN GUM"],"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 contains : sodium 5 mg each 15 mL contains : salicylate 206 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)"],"version":"5","warnings":["Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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 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 diabetes gout arthritis anticoagulation (thinning the blood) 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 childen. In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away."],"when_using":["When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur."]}