{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Kroger Regular Strength Pink Bismuth Bismuth Subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C RED NO. 22 D&C RED NO. 28 MICROCRYSTALLINE CELLULOSE POTASSIUM HYDROXIDE POTASSIUM SORBATE WATER SALICYLIC ACID DIMETHICONE, UNSPECIFIED SODIUM BENZOATE SUCRALOSE XANTHAN GUM viscous" ], "active_ingredient": [ "Active ingredient (in each 30 mL dose) Bismuth subsalicylate 525 mg" ], "purpose": [ "Purposes Upset stomach reliever and antidiarrheal" ], "indications_and_usage": [ "Uses relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness" ], "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 or 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 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 or last more than 2 days 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 right away at (1-800-222-1222)." ], "do_not_use": [ "Do not use if you have an ulcer a bleeding problem bloody or black stool" ], "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" ], "when_using": [ "When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur" ], "stop_use": [ "Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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 at (1-800-222-1222)." ], "dosage_and_administration": [ "Directions shake well before use only use dose cup provided adults and children 12 years and over: 30 mL 1 (dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (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" ], "storage_and_handling": [ "Other information each 30 mL contains: sodium 10 mg salicylate 261 mg low sodium sugar free store at room temperature protect from freezing avoid excessive heat (over 104°F or 40°C)" ], "inactive_ingredient": [ "Inactive ingredients carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum" ], "questions": [ "Questions or comments? 1-866-467-2748 DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN." ], "package_label_principal_display_panel": [ "Principal Display Panel *C OMPARE TO the active ingredient in PEPTO-BISMOL® REGULAR STRENGTH *See side panel Regular Strength Stomach Relief Bismuth Subsalicylate 525 mg Upset Stomach Reliever/Antidiarrheal Original Flavor 5 SYMPTOM RELIEF RELIEF: Heartburn Indigestion Nausea Upset Stomach Diarrhea *This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol ® Regular Strength. Package Label 236 mL Regular Strength Stomach Relief 236 mL Package Label 354 mL Regular Strength Stomach Relief 354 mL" ], "set_id": "97175691-4881-450d-a14c-3413ab47a3ca", "id": "5a7d7bbc-e2f7-e67a-e063-6294a90ada02", "effective_time": "20260902", "version": "8", "openfda": { "application_number": [ "M008" ], "brand_name": [ "Kroger Regular Strength Pink Bismuth" ], "generic_name": [ "BISMUTH SUBSALICYLATE" ], "manufacturer_name": [ "KROGER COMPANY" ], "product_ndc": [ "30142-608" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BISMUTH SUBSALICYLATE" ], "rxcui": [ "308762" ], "spl_id": [ "5a7d7bbc-e2f7-e67a-e063-6294a90ada02" ], "spl_set_id": [ "97175691-4881-450d-a14c-3413ab47a3ca" ], "package_ndc": [ "30142-608-08", "30142-608-12", "30142-608-16", "30142-608-32" ], "is_original_packager": [ true ], "upc": [ "0041260010071", "0041260010026" ], "nui": [ "M0002611", "N0000180183" ], "pharm_class_cs": [ "Bismuth [CS]" ], "pharm_class_epc": [ "Bismuth [EPC]" ], "unii": [ "62TEY51RR1" ] } } ] }