Phenazopyridine

DRUG INFORMATION

  ADULT
    - 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
    - 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

  CHILD
    - 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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