{"active_ingredient":["Active ingredient (in each tablet) Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)"],"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 bloody or black stool an ulcer a bleeding problem"],"dosage_and_administration":["Directions chew or dissolve in mouth Adults and children 12 years and over: 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) in 24 hours use until diarrhea stops but not more than 2 days Children under 12 years of age: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea"],"effective_time":"20171222","id":"affef754-2097-48fc-975b-63a35c991da7","inactive_ingredient":["Inactive Ingredients acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide"],"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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M008"],"brand_name":["Pep Tum"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["First Aid Direct"],"nui":["M0002611","N0000180183"],"package_ndc":["53117-046-85"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["53117-046"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308761"],"spl_id":["affef754-2097-48fc-975b-63a35c991da7"],"spl_set_id":["bf966e9f-2f95-41cd-a6e5-b8eb521181d8"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel Pep Tum Pep Tum"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antidiarrheal/Antacid"],"set_id":"bf966e9f-2f95-41cd-a6e5-b8eb521181d8","spl_product_data_elements":["Pep Tum Bismuth subsalicylate BISMUTH SUBSALICYLATE SALICYLIC ACID ASPARTAME CALCIUM CARBONATE D&C RED NO. 27 DEXTRATES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE RH046"],"spl_unclassified_section":["Other Information Phenylketonurics: contains phenylalanine 1.1mg per tablet Calcium content per tablet: 73mg store at room temperature 15°– 30°C (59°– 86°F) avoid excessive heat (over 40°C or 104°F) do not use if cellophane unit is torn"],"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"],"version":"8","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 bloody or black stool an ulcer a bleeding problem Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis 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 When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. If pregnant or breast-feeding, ask a health professional before use."],"when_using":["When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur."]}