{"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":"20250711","id":"61f89479-7da0-4f57-b505-d7ad3c2c52cb","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"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"nui":["M0002611","N0000180183"],"package_ndc":["0904-7205-46"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["0904-7205"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308761"],"spl_id":["61f89479-7da0-4f57-b505-d7ad3c2c52cb"],"spl_set_id":["2a7c9cc1-206e-4018-b89d-7b634df43df6"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL MAJOR NDC 0904-7205-46 *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 3-122-30-maj-o.jpg"],"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":"2a7c9cc1-206e-4018-b89d-7b634df43df6","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"]}