■ 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 for up to two days. ■ 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.govActive ingredient (in each tablet)
Phenazopyridine HCl 97.5 mg
Purpose
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 Hydrochloride
Caution Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
■ 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.
Keep out of reach of children
In case of 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 for up to two days.
■ 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
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
carnauba wax, corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide.
1-800-231-4670
Caution: Tablets sealed in blister. Do not use if blister is opened or damaged
*This product is not manufactured or distributed by i-Health, Inc., distributor of AZO Urinary Pain Relief® Maximum Strength.
Distributed by: CVS Pharmacy, Inc. One CVS Drive,
Woonsocket, RI 02895 © 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-34571
CVSHealth
Compare to the active ingredient in AZO Urinary Pain Relief® Maximum Strength*
MAXIMUM STRENGTH
Urinary Pain Relief
PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg
Quickly eases urinary pain, burning & urgency
• More active ingredient for maximum relief
• Provides targeted relief for urinary pain
24 Tablets Individually Sealed
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69842-538 | 69842-538-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| PHENAZOPYRIDINE HYDROCHLORIDE | 0EWG668W17 | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | 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 |
|---|---|---|---|---|---|---|
| 8f0ee43b-27c4-05bf-e053-2a95a90ac659 | 6de5a7ef-9b1b-8bf8-e053-2a91aa0aba14 | 2019-08-21 | Warnings | 8f0ee43b-27c4-05bf-e053-2a95a90ac659 6de5a7ef-9b1b-8bf8-e053-2a91aa0aba14 |
Adverse event summaries are temporarily unavailable. Other product information remains available.