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 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ Children under 12: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Phenazopyridine Hydrochloride 95 mg
Urinary Tract Analgesic
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Do not exceed recommended dosage
■ 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
ask a health professional before use.
in case of an overdose,get medical help or contact a Poison Control Center right away.
■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
lactose, magnesium silicate, magnesium stearate, microcrystalline
cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch,
croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide.
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70000-0243-1 | Leader Urinary Pain Relief | 30 in 1 BLISTER PACK | TABLET | 30 | 5 | |
| 70000-0243-1 | Leader Urinary Pain Relief | 1 in 1 CARTON | TABLET | 1 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0243 | LEADER URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241220_d1d1d4de-ab20-40fa-a6cf-53d805c7ecb3.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0243-1 | EA - Each | 70000-0243 | 2d1fee72-a2ff-440f-b4a6-be0fc3d922d5 | 1 | 2017-12-14 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70000-0243 | 70000-0243-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENAZOPYRIDINE HYDROCHLORIDE | 0EWG668W17 | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SHELLAC | 46N107B71O | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| MAGNESIUM SILICATE | 9B9691B2N9 | IACT |
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 |
|---|---|---|---|---|---|---|
| Leader Urinary Pain Relief | PHENAZOPYRIDINE HYDROCHLORIDE | Cardinal Health | d1d1d4de-ab20-40fa-a6cf-53d805c7ecb3 | 2024-12-18 | Warnings | 70000-0243-1 70000-0243 70000024301 941e2a47-36d1-4ebd-938e-759b3ea9e1e4 d1d1d4de-ab20-40fa-a6cf-53d805c7ecb3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.