{"active_ingredient":["Active ingredient (in each 30 mL dose cup or 2 tablespoons) Bismuth subsalicylate 1050 mg"],"ask_doctor":["Ask a doctor before use if you have ■ fever ■ mucus in 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 ■ an ulcer ■ a bleeding problem ■ black or bloody stool"],"dosage_and_administration":["Directions. Shake well before use ■ use dose cup or tablespoon (TBSP) ■ adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1 hour as needed ■ do not exceed 4 doses (120 mL or 8 TBSP) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ children under 12 years: ask adoctor ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea"],"effective_time":"20231230","id":"22de45fb-431e-41c3-aafc-f9d8655dc60a","inactive_ingredient":["Inactive ingredients benzoic acid, D&C red #22, D&C red # 28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xantham gum"],"indications_and_usage":["Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach due to overindulgence of food and drink including: ■ heart burn ■ indigestion ■ nausea ■ gas ■ belching"],"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 right away."],"openfda":{"application_number":["M008"],"brand_name":["Stomach Relief, Maximum Strength"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["AptaPharma Inc."],"nui":["M0002611","N0000180183"],"package_ndc":["76281-558-25"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["76281-558"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308763"],"spl_id":["22de45fb-431e-41c3-aafc-f9d8655dc60a"],"spl_set_id":["cdd436f6-b769-49aa-9e6c-da512da9e6e3"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"]},"other_safety_information":["Other information ■ each 30 mL dose cup contains : sodium 13 mg, salicylate 455 mg ■ protect from freezing ■ avoid excessive heat (over 104ºF or 40ºC) ■ Low sodium"],"package_label_principal_display_panel":["Principal Display Panel AP SAFE ® NDC 76281-558-25 *COMPARE TO the active ingredient in PEPTO-BISMOL™ MAXIMUM STRENGTH Stomach Relief Bismuth Subsalicylate Antidiarrheal/Upset Stomach Reliever Maximum Strength 5 Symptom Relief of: ● Nausea ● Heartburn ●Indigestion ● Upset stomach ● Diarrhea 6 FL OZ (177 mL) TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken *This product is not manufactured or distributed by Procter & Gamble, Inc., the distributor of Pepto-Bismol™. Manufactured by: AptaPharma Inc., Made in USA 1533 Union Ave. AP-LR-13 Pennsauken, NJ 081 LOT. EXP. res 558-25 6OZ"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask health professional before use."],"purpose":["Purposes Bismuth subsalicylate .............. Upset stomach reliever and antidiarrheal"],"questions":["Questions? 1-877-798-5944"],"set_id":"cdd436f6-b769-49aa-9e6c-da512da9e6e3","spl_product_data_elements":["Stomach Relief, Maximum Strength BISMUTH SUBSALICYLATE BISMUTH SUBSALICYLATE SALICYLIC ACID BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 WATER SACCHARIN SODIUM SALICYLIC ACID SODIUM SALICYLATE XANTHAN GUM"],"spl_unclassified_section":["Drug Facts","Allergy alert: Contains salicylate. Do not take if you are ■ allergic to salicylates (including aspirin) ■ taking other salicylate products"],"stop_use":["Slop use and ask a doctor if ■ diarrhea lasts more than 2 days ■ symptoms get worse or last more than 2 days ■ ringing in the ears or loss of hearing occurs"],"version":"2","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."],"when_using":["When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur"]}