{"active_ingredient":["Active ingredient (in each pouch) Bismuth Subsalicylate 262 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"],"dosage_and_administration":["Directions Adults & Children 12 yrs and older: Dissolve 2 pouches (1 dose) in 1/2 glass of water. Repeat every 1/2 to 1 hour as needed, to a maximum of 8 doses in a 24-hour period use until diarrhea stops, but not more than 2 days. If symptoms persist, consult a doctor drink plenty of clear fluids to help prevent dehydration which may accompany diarrhea Children under 12 yrs: ask a doctor"],"effective_time":"20231129","id":"b60909fc-e262-4ad4-bb96-e09b71b38e1c","inactive_ingredient":["Inactive ingredients anhydrous citric acid, calcium carbonate, magnesium hydroxide, maltodextrin, silicon dioxide, sodium bicarbonate, tartaric acid"],"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 the reach of children. In case of overdose, seek professional help or contact a poison control center immediately"],"openfda":{"application_number":["M008"],"brand_name":["Estomaquil Polvo"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["ProMex LLC"],"nui":["M0002611","N0000180183"],"package_ndc":["58988-1080-1","58988-1080-2","58988-1080-3"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["58988-1080"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1721449","1721455"],"spl_id":["b60909fc-e262-4ad4-bb96-e09b71b38e1c"],"spl_set_id":["cf94c99a-c489-45ec-bb13-3e6959e377de"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 3.0 g Pouch Carton ESTOMAQUIL ® Bismuth Subsalicylate 262 mg Relief for: Nausea Heartburn Diarrhea Fullness Maximum Strength 10 Pouches 0.1 oz (3.0 g) Each Principal Display Panel - 3.0 g Pouch Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Upset stomach reliever / Antidiarrheal"],"set_id":"cf94c99a-c489-45ec-bb13-3e6959e377de","spl_product_data_elements":["Estomaquil Polvo BISMUTH SUBSALICYLATE BISMUTH SUBSALICYLATE SALICYLIC ACID CALCIUM CARBONATE CITRIC ACID MONOHYDRATE MAGNESIUM HYDROXIDE SODIUM BICARBONATE TARTARIC ACID MALTODEXTRIN SILICON DIOXIDE"],"spl_unclassified_section":["Drug Facts","Distributed By: PRO-MEX ® P.O. Box 63-0716 Miami, FL. 33163"],"stop_use":["Stop use and ask a 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 pouch contains: calcium 210 mg, magnesium 190 mg, sodium 206 mg avoid excessive heat"],"version":"4","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 salicylate (including aspirin) taking other salicylate products Do not use if you have an ulcer a bleeding problem 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 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 the reach of children. In case of overdose, seek professional help or contact a poison control center immediately"],"when_using":["When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur"]}