{"active_ingredient":["ACTIVE INGREDIENT(in each tablet) Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)"],"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 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 • chew or dissolve in mouth • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed • do not take more than 8 doses (16 tablets) in 24 hours • children under 12 years: ask a doctor • drink plenty of clear fluids to help prevent dehydration caused diarrhea"],"effective_time":"20260320","id":"6ad4aa56-96a5-413c-8abd-dec8ead6bb1a","inactive_ingredient":["INACTIVE INGREDIENTS calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium"],"indications_and_usage":["USE(S) relieves: • diarrhea • heartburn • indigestion • nausea • upset stomach associated with these symptoms"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."],"openfda":{"application_number":["M008"],"brand_name":["Major Bismuth Subsalicylate"],"generic_name":["BISMUTH SUBSALICYLATE"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"nui":["M0002611","N0000180183"],"original_packager_product_ndc":["0904-7205"],"package_ndc":["68788-8239-3"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["68788-8239"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308761"],"spl_id":["6ad4aa56-96a5-413c-8abd-dec8ead6bb1a"],"spl_set_id":["69b9999f-c2e5-43a6-891f-0e24d3c343a4"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL MAJOR NDC 68788-8239-3 *Compare to the active ingredient in Pepto-Bismol ® Bismuth Subsalicylate 262 mg Upset Stomach Reliever / Anti-diarrheal Soothing, coating action provides fast relief for heartburn, indigestion nausea, upset stomach and diarrhea 30 Chewable Tablets Relabeled By: Preferred Pharmaceuticals Inc. Bismuth Subsalicylate Tablets 262mg"],"pregnancy_or_breast_feeding":["IF PREGNANT OR BREAST-FEEDING, ask a health professional before use."],"purpose":["PURPOSE Upset stomach reliever and anti-diarrheal"],"set_id":"69b9999f-c2e5-43a6-891f-0e24d3c343a4","spl_product_data_elements":["Major Bismuth Subsalicylate Bismuth subsalicylate BISMUTH SUBSALICYLATE SALICYLIC ACID CALCIUM CARBONATE D&C RED NO. 27 MAGNESIUM STEARATE MANNITOL STARCH, CORN SACCHARIN SODIUM G122"],"stop_use":["STOP USE AND ASK 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 tablet contains: • sodium less than 1 mg • salicylate 102 mg • very low sodium • avoid excessive heat (over 104 o F or 40 o C) • TAMPER EVIDENT: Do not use if individual compartments are torn on open."],"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 behaviour 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"],"when_using":["WHEN USING THIS PRODUCT a temporary, but harmless darkening of the stool and/or tongue may occur"]}