{"active_ingredient":["Active ingredient (in each tablet) 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 if you are taking any drug for anticoagulation (thinning of 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 do not use more than directed chew or dissolve in mouth use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea do not exceed 16 tablets (4,200mg) in 24 hours Adults and children: (12 years and older) Take 2 tablets (525mg) every 1/2 to 1 hour or 4 tablets (1,050mg) every hour as needed Children under 12 years: Do not give to children under 12 years of age."],"effective_time":"20141114","id":"07d585ce-389d-349a-e054-00144ff8d46c","inactive_ingredient":["Inactive ingredients aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, microcrystalline cellulose, silicon dioxide"],"indications_and_usage":["Uses Temporarily relieves traveler's diarrhea diarrhea upset stomach reliever due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness"],"keep_out_of_reach_of_children":["Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately."],"openfda":{},"package_label_principal_display_panel":["220R Medique Diotame Label Medique ® Diotame Bismuth Subsalicylate Indigestion •Upset Stomach •Heartburn Diarrhea •Nausea Pull To Open Chewable Tablets 100 Tablets (50 x 2) Tamper Evident Unit Dose Packets 220R Medique Diotame Label"],"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? 1-800-634-7680"],"set_id":"812bf7a4-0d90-4935-aaef-58b2f7e27059","spl_product_data_elements":["Medique Diotame BISMUTH SUBSALICYLATE ASPARTAME CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE D&C RED NO. 27 DEXTRATES MAGNESIUM STEARATE SILICON DIOXIDE BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID pink ROUND RH;046"],"spl_unclassified_section":["Drug Facts","Other information phenylketonurics: contains phenylalanine 1.1mg per tablet each tablet contains 73mg elemental calcium store at room temperature 59°-86°F (15°-30°C) tamper-evident sealed packets do not use any opened or torn packets"],"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 When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. If pregnant or breast-feeding, ask a health professional before use."],"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 bloody or black stool an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of 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 and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. If pregnant or breast-feeding, ask a health professional before use."],"when_using":["When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena."]}