{"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 (1 dose) every 1/2 hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 15 mL (1 dose) every 1/2 as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) children under 12 years of age: ask a doctor"],"effective_time":"20240416","id":"2098abda-1027-4fc4-b273-2a0f39316a41","inactive_ingredient":["Inactive ingredients benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid"],"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 Strength"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["P & L Development, LLC"],"nui":["M0002611","N0000180183"],"package_ndc":["49580-0842-8"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["49580-0842"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308763"],"spl_id":["2098abda-1027-4fc4-b273-2a0f39316a41"],"spl_set_id":["cb5ca7ab-39cf-4b07-ac22-a00b214db102"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"],"upc":["0349580842090"]},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredient in Pepto-Bismol® Ultra* Ultra Stomach Relief Bismuth subsalicylate 525 mg 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. TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. Manufactured by: PL Developments 11865 S. Alameda St Lynwood, CA 90262","Package Label READYinCASE Stomach Relief Ultra Bismuth Subsalicylate 525 mg"],"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 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"cb5ca7ab-39cf-4b07-ac22-a00b214db102","spl_product_data_elements":["Stomach Relief Ultra Strength Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 MAGNESIUM ALUMINUM SILICATE WATER SACCHARIN SODIUM SALICYLIC ACID SODIUM SALICYLATE SORBIC ACID METHYLCELLULOSE (1500 CPS)"],"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 6 mg each 15 mL contains : salicylate 227 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)"],"version":"3","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 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."]}