Indications and uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
■ Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ Children under 12 years: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Phenazopyridine Hydrochloride 95 mg
Urinary Analgesic
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Do not exceed recommended dosage
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine
■ When using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset
■ your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.
■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication
Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
ask a health professional before use.
in case of an overdose,get medical help or contact a Poison Control Center right away 1-800-222-1222.
■ Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12 years: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
■ this product may stain contact lenses
■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light
lactose, corn starch, croscarmellose sodium, microcrystalline
cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate,
pregelatinized starch, silicon dioxide, talc, and triacetin.
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0536-1411-07 | Rugby Phenazopyridine HCl Urinary Tract Analgesic | 30 in 1 BLISTER PACK | TABLET | 30 | 2 | |
| 0536-1411-07 | Rugby Phenazopyridine HCl Urinary Tract Analgesic | 1 in 1 CARTON | TABLET | 1 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1411-07 | EA - Each | 0536-1411 | cebab2d4-4fbb-4479-ade0-8c20c6fe5efc | 1 | 2024-04-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0536-1411 | 0536-1411-07 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Rugby Phenazopyridine HCl Urinary Tract Analgesic | PHENAZOPYRIDINE HYDROCHLORIDE | Rugby Laboratories | 7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc6 | 2024-12-18 | Warnings | 0536-1411-07 0536-1411 00536141107 6d75180f-33bf-41dc-82c1-7c193aac68c4 7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.