{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "phenazopyridine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "mg Tablets: Average adult dosage is two tablets 3 times a day after meals. 200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals.",
        "source": "US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": true
      },
      {
        "text": "mg Tablets: Average adult dosage is two tablets 3 times a day after meals. 200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine Hydrochloride should not exceed 2 days.",
        "source": "US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Children Adequate and well-controlled studies have not been performed in the pediatric population. No pediatric-specific problems have been documented.",
        "source": "US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Category B Reproductive studies with Phenazopyridine Hydrochloride (in combination with sulfacytine) in rats given up to 110 mg/kg/day and in rabbits given up to 39 mg/kg/day during organogenesis revealed no evidence of harm to offspring.",
        "source": "US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": true
      },
      {
        "text": "One prospective study in humans demonstrated that Phenazopyridine Hydrochloride traverses the placenta into the fetal compartment.",
        "source": "US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": true
      },
      {
        "text": "There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known whether Phenazopyridine Hydrochloride or its metabolites are excreted in human milk.",
        "source": "US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are excreted in human milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of drug therapy to the mother.",
        "source": "US FDA label for phenazopyridine (Phenazopyridine Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/phenazopyridine.json",
        "verbatim": true
      }
    ]
  }
}