■ adults and children 12 years of age and over: Take 2 tablets 3 times daily with a full glass of water, with or after meals as needed. ■ children under 12 years of age: consult a doctor ■ Do not use for more than 2 days (12 tablets) without consulting a doctor
www.P65Warnings.ca.gov
www.myleader.comActive ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
Purpose
Urinary tract analgesic
relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Do not exceed recommended dosage
Ask a doctor before use if you have
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine Hydrochloride
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
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.
Stop use and ask a doctor if
■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication.
If pregnant or breast-feeding, ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.
Keep out of reach of children.
In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
■ adults and children 12 years of age and over: Take 2 tablets 3 times daily with a full glass of water, with or after meals as needed.
■ children under 12 years of age: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
■ This product may stain contact lenses and other items if handled after touching tablets
■ This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
■ Long term administration of phenazopyridine HCI 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
■ Store at room temperature 15°-30°C (59°-86°F) in a dry place and protect from light.
carnauba wax, corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch and silica.
(800) 231-4670
CAUTION: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED.
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
WARNING This product can expose you to Phenazopyridine Hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov
*This product is not manufactured or distributed by i-Health, Inc., owner of the registered trademark AZO Urinary Pain Relief®.
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
1-800-200-6313
Essential to Care™ since 1979
2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.
LEADER TM
NDC 70000-0031-1
Urinary Pain Relief
Phenazophyridine Hydrochloride Tablets, 95 ng
Urinary Tract Analgesic
COMPARE TO AZO URINARY PAIN RELIEF® active ingredient*
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30 Tablets individually sealed
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70000-0031 | 70000-0031-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PHENAZOPYRIDINE HYDROCHLORIDE | 0EWG668W17 | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | 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 |
|---|---|---|---|---|---|---|
| 8de347a4-edcc-44c5-e053-2a95a90ae0a9 | 89671985-3829-62cd-e053-2995a90a6113 | 2019-07-17 | Warnings | 89671985-3829-62cd-e053-2995a90a6113 |
Adverse event summaries are temporarily unavailable. Other product information remains available.