Phenazopyridine is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it p...
100 mg Tablets: Average adult dosage is two tablets 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 HCl should not exceed 2 days.
Phenazopyridine is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of
Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when
symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible
with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed two days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after two days. (See DOSAGE AND ADMINISTRATION section.)
100 mg Tablets: Average adult dosage is two tablets 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 HCl should not exceed 2 days.
Phenazopyridine HCl Tablets, USP contains the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methyl cellulose, magnesium stearate, maize (corn starch) microcrystalline cellulose, polyethylene glycol, povidone and pregelatinized starch.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70795-1241-0 | 2024-01-30 | C162847 | 48780-1 | 1030e365-41da-111a-e063-dadaa90a10e2 | Phenazopyridine Hydrochloride tablet, film coated - 100 mg, 70795-1241 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70795-1241-0 | Phenazopyridine Hydrochloride100 mg | 100 in 1 BOTTLE | TABLET | 100 | 6 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70795-1241 | PHENAZOPYRIDINE HYDROCHLORIDE 100 MG (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [GRAXCELL PHARMACEUTICAL, LLC] | 6 | Legacy NDC, 1 package rows | 20211222_860f30ef-cfe3-4c35-8baf-dd788f02ac94.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70795-1241-0 | EA - Each | 70795-1241 | dc56cdd8-aeae-448a-a7c1-f941083efdde | 1 | 2022-06-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70795-1241 | 70795-1241-0 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PHENAZOPYRIDINE HYDROCHLORIDE | 0EWG668W17 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| d3aebf99-bad3-2744-e053-2995a90a9d3e | 860f30ef-cfe3-4c35-8baf-dd788f02ac94 | 2021-12-21 | d3aebf99-bad3-2744-e053-2995a90a9d3e 860f30ef-cfe3-4c35-8baf-dd788f02ac94 |
Adverse event summaries are temporarily unavailable. Other product information remains available.