{
  "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": [
        "Ultra Strength digestive relief Bismuth subsalicylate BISMUTH SUBSALICYLATE SALICYLIC ACID CALCIUM CARBONATE CROSPOVIDONE (120 .MU.M) D&C RED NO. 27 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 Caplet RP130"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient (in each caplet) Bismuth Subsalicylate 525 mg"
      ],
      "purpose": [
        "Purpose 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 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 ▪ 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."
      ],
      "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."
      ],
      "dosage_and_administration": [
        "Directions ▪ swallow with water, do not chew ▪ adults and children 12 years and over: 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea ▪ 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) ▪ do not exceed 8 doses (8 caplets) 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 caplet contains: calcium 54 mg ▪ salicylate 199 mg ▪ store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients calcium carbonate, crospovidone, FD&C Red No. 27 Lake, magnesium stearate, microcrystalline cellulose, polysorbate 80."
      ],
      "questions": [
        "Questions? 1-866-467-2748"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 24 Caplet Carton NDC 30142-138-24 Ultra Strength Bismuth Subsalicylate Upset Stomach Reliever/Antidiarrheal Symptom Digestive Relief • Heartburn • Indigestion • Nausea • Upset Stomach • Diarrhea 24 Caplets 2X STRENGTH per caplet* Ultra Strength Digestive Relief 24 Caplets"
      ],
      "set_id": "5e288108-1578-4379-a3d6-44b447187643",
      "id": "81c2e281-5874-4fe3-833a-9f41359f1531",
      "effective_time": "20260901",
      "version": "8",
      "openfda": {
        "application_number": [
          "M008"
        ],
        "brand_name": [
          "Ultra Strength digestive relief"
        ],
        "generic_name": [
          "BISMUTH SUBSALICYLATE"
        ],
        "manufacturer_name": [
          "THE KROGER CO."
        ],
        "product_ndc": [
          "30142-138"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BISMUTH SUBSALICYLATE"
        ],
        "rxcui": [
          "1998447"
        ],
        "spl_id": [
          "81c2e281-5874-4fe3-833a-9f41359f1531"
        ],
        "spl_set_id": [
          "5e288108-1578-4379-a3d6-44b447187643"
        ],
        "package_ndc": [
          "30142-138-24"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041260008542"
        ],
        "nui": [
          "M0002611",
          "N0000180183"
        ],
        "pharm_class_cs": [
          "Bismuth [CS]"
        ],
        "pharm_class_epc": [
          "Bismuth [EPC]"
        ],
        "unii": [
          "62TEY51RR1"
        ]
      }
    }
  ]
}