Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo

Inclusion Criteria: * Diagnosis of uncomplicated urinary tract infection (uUTI) * Must have one of the following uUTI diagnosis * Cystitis * Urethritis * A Positive urine dipstick test showing nitrate or leukocyte esterase (LE) * Negative pregnancy test (if applicable) * Must have one or both of the following symptoms of * pain upon urination * burning upon urination * In addition, one of the following symptoms * Not being able to empty bladder completely * Pain or discomfort in lower abdomen, or pelvic areas * Frequent urge to urinate * Blood in urine * None Exclusion Criteria: * Any diagnosis of a urinary tract or kidney disorder that is not a uUTI * A diagnosis of Pyelonephritis (kidney infections when lower uUTI spreads to the upper tract) * Women with a history of prior use of phenazopyridine hydrochloride * Women who have taken any systemic anti-infectives within seven days of study participation * Women with a history of G-6-PD deficiency or hemolytic anemia * Women who have a known history of anatomical genitourinary (GU) anomalies or GU surgery within the past 6 months * Women of child bearing age who do not consent to a pregnancy test * Women who are lactating * Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy * Subjects with clinically significant abnormal results or finding on the screening physical examination, laboratory tests, vital signs or ECG. * Subjects unable to comprehend the language of the informed consent and the self evaluation scales. * Subjects with serious acute illness (e.g. pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uUTI * Subjects who have received an investigational medication as part of a drug trial 3 months prior to the baseline study visit * Subjects with a history of severe drug allergy or hypersensitivity * Subjects with a known sensitivity to Phenazopyridine, Hyoscyamine, Butabarbital and antibiotics. * Employees of the investigator or the institution who have direct involvement in the trial or other trials under the direction of the investigator or their associates.