{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "bismuth subcitrate+metronidazole+tetracycline",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "One omeprazole 20 mg capsule should be taken twice a day with bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules after the morning and evening meal for 10 days ( Table 1 ).",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      },
      {
        "text": "( 2 ) Administer bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules with omeprazole 20 mg twice daily (after the morning and evening meals).",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      },
      {
        "text": "Administer three bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules 4 times a day (after meals and at bedtime) for 10 days. One omeprazole 20 mg capsule should be taken twice a day with bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules after the morning and evening meal for 10 days ( Table 1 ).",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "No child dose in this label. That usually means untested in children, not unsuitable - use a paediatric source.",
        "source": "Read and found silent: the US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": false
      }
    ],
    "renal": [
      {
        "text": "Because elderly patients are more likely to have decreased renal function, additional monitoring may be required [see Contraindications (4.4) ]. 8.6 Renal Impairment The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN).",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      },
      {
        "text": "In patients with severe renal impairment, higher serum concentrations of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis [see Contraindications (4.4) ]. 8.7 Hepatic Impairment Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma.",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "In patients with severe renal impairment, higher serum concentrations of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis [see Contraindications (4.4) ]. 8.7 Hepatic Impairment Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma.",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      },
      {
        "text": "Patients with mild to moderate hepatic impairment should be monitored for metronidazole associated adverse events.",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      },
      {
        "text": "Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride is not recommended in patients with severe hepatic impairment [see Warnings and Precautions (5.11) and Clinical Pharmacology (12.3) ].",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Administration of oral tetracycline to pregnant rats at various doses resulted in yellow fluorescence in teeth and bones in the newborn animals.",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      },
      {
        "text": "There are maternal risks with high intravenous doses of tetracycline [see Clinical Considerations].",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      },
      {
        "text": "Metronidazole usage in pregnancy has been associated with certain congenital anomalies [see Data].",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Safety and effectiveness of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride in pediatric patients infected with Helicobacter pylori have not been established.",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      },
      {
        "text": "Tetracycline use in children may cause permanent discoloration of the teeth.",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      },
      {
        "text": "Enamel hypoplasia has also been reported.",
        "source": "US FDA label for bismuth subcitrate (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/bismuth-subcitrate-metronidazole-tetracycline.json",
        "verbatim": true
      }
    ]
  }
}