{"active_ingredient":["Active ingredient Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)"],"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 bloody or black stool"],"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 ½ 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 no 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 Other Information Phenylketonurics: contains phenylalanine 1.1 mg per tablet Calcium content per tablet: ·73 mg • save carton for full directions and warnings • store at room temperature 15°- 30°C (59°- 86°F)"],"effective_time":"20250607","id":"4eb5995d-4af4-40fd-ac62-a4906fac1aea","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, contact a doctor or Poison Control Center (1-800-222-1222) right away."],"openfda":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel Bismuth Subsalicylate 262 mg Chewable Tablet Mfg: Allegiant Health Exp:02/03/24 Lot22A0016 PKG BY: Safecor Health Woburn, MA 4843312701 Safecor Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purpose Antidiarrheal/Antacid"],"set_id":"ba4d807b-4c9b-48ba-a8ea-1f6358a825d7","spl_product_data_elements":["Bismuth Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION ASPARTAME CALCIUM CARBONATE D&C RED NO. 27 DEXTRATES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE ACACIA MALTODEXTRIN PEPPERMINT RH046"],"spl_unclassified_section":["BISMUTH SUBSALICYLATE 262 mg Chewable Tablet Contains 100 Unit Dose Blisters NDC: 48433-127-01 3 48433 127 10 0 GTIN: 00348433127100 SN: 222202401 Exp: 2024-03-27 Lot: 22A0078 These unit dose packages meet USP specifications for light resistance. The package design is not child resistant. For institutional use only. Distributed by Safecor Health, LLC 317 New Boston St, Woburn MA 01801 06/2022 PN5728"],"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":"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 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 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"]}