{"active_ingredient":["Active ingredient (in each 15 mL tbsp) 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 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 shake well before use for accurate dosing, use dose cup adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (16 tbsp or 240 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea"],"effective_time":"20251203","id":"13b52b6e-d8cb-476e-a8af-e6df6d02b22f","inactive_ingredient":["Inactive ingredients benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum."],"indications_and_usage":["Uses relieves: diarrhea heartburn indigestion nausea upset stomach associated with these symptoms"],"keep_out_of_reach_of_children":[""],"openfda":{"application_number":["M008"],"brand_name":["Pink-Bismuth"],"generic_name":["BISMUTH SUBSALICYLATE"],"is_original_packager":[true],"manufacturer_name":["Guardian Drug Company"],"nui":["M0002611","N0000180183"],"package_ndc":["53041-527-06","53041-527-05","53041-527-04","53041-527-03"],"pharm_class_cs":["Bismuth [CS]"],"pharm_class_epc":["Bismuth [EPC]"],"product_ndc":["53041-527"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308762"],"spl_id":["13b52b6e-d8cb-476e-a8af-e6df6d02b22f"],"spl_set_id":["cb7da2b4-5e44-488b-a6e7-362e9b06c49c"],"substance_name":["BISMUTH SUBSALICYLATE"],"unii":["62TEY51RR1"]},"package_label_principal_display_panel":["Principal Display Panel compare to the active ingredient in pepto-bismol ® Pink-Bismuth Regular Strength Protective coating Bismuth subsalicylate Anti-diarrheal/Upset stomach reliever Soothing Relief For: upset stomach Indigestion Nausea Heartburn Diarrhea 16 FL OZ (473 mL) Bismuth label"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison control center immediately."],"purpose":["Purpose Upset stomach reliever and anti-diarrheal"],"set_id":"cb7da2b4-5e44-488b-a6e7-362e9b06c49c","spl_product_data_elements":["Pink-Bismuth Bismuth Subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) POTASSIUM HYDROXIDE WATER SACCHARIN SODIUM SALICYLIC ACID DIMETHICONE XANTHAN GUM"],"spl_unclassified_section":[""],"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"],"storage_and_handling":["Other information each Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C) TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken ."],"version":"6","warnings":["Warnings Reye's syndrome: Children and teenagers who have or are recovering from children 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 before use if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis When using this product a temporary, but harmless darkening of the stool and/or tongue may occur 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 If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison control center immediately."],"when_using":["When using this product a temporary, but harmless darkening of the stool and/or tongue may occur"]}