{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Upset Stomach Relief-Bismuth Subsalicylate 262 mg Bismuth Subsalicylate 262 mg BISMUTH SUBSALICYLATE SALICYLIC ACID POLYETHYLENE GLYCOL 400 POLYSORBATE 80 SOYBEAN LECITHIN POVIDONE K30 Gelatin Glycerin SORBITOL SOLUTION SORBITAN D&C RED NO. 33 Titanium Dioxide WATER Opaque baby pink Oblong SD30"
      ],
      "active_ingredient": [
        "Active Ingredient (in each softgel) Bismuth subsalicylate 262 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": [
        "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 (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions ■ swallow with water, do not chew ■ adults and children 12 years and over: ■ 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea ■ 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) ■ do not exceed 8 doses (16 softgels) 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"
      ],
      "spl_unclassified_section": [
        "Other information ■ each softgel contains: ■ salicylate 99 mg ■ low sodium ■ do not exceed 25°C"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Polyethylene Glycol-400, Polysorbate 80, Soya Lecithin, Povidone (PVPK 30), Gelatin, Glycerin, Sorbitol Sorbitan Solution, D & C Red 33 , Titanium Dioxide, Purified Water"
      ],
      "questions": [
        "Questions or Comments? Call +1 (732) 994-2808 or email support@gencare.health"
      ],
      "package_label_principal_display_panel": [
        "PL0275-00 GC Bismuth Subsalicylate Softgels 48ct"
      ],
      "set_id": "07e2cc82-ab0e-46c5-863b-67658b612678",
      "id": "3eab8dc9-d54c-4921-864f-a944cbb43a7c",
      "effective_time": "20250627",
      "version": "1",
      "openfda": {
        "application_number": [
          "M008"
        ],
        "brand_name": [
          "Upset Stomach Relief-Bismuth Subsalicylate 262 mg"
        ],
        "generic_name": [
          "BISMUTH SUBSALICYLATE 262 MG"
        ],
        "manufacturer_name": [
          "Pioneer Life Sciences, LLC"
        ],
        "product_ndc": [
          "72090-053"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BISMUTH SUBSALICYLATE"
        ],
        "rxcui": [
          "2121072"
        ],
        "spl_id": [
          "3eab8dc9-d54c-4921-864f-a944cbb43a7c"
        ],
        "spl_set_id": [
          "07e2cc82-ab0e-46c5-863b-67658b612678"
        ],
        "package_ndc": [
          "72090-053-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0372090004740"
        ],
        "nui": [
          "M0002611",
          "N0000180183"
        ],
        "pharm_class_cs": [
          "Bismuth [CS]"
        ],
        "pharm_class_epc": [
          "Bismuth [EPC]"
        ],
        "unii": [
          "62TEY51RR1"
        ]
      }
    }
  ]
}