AZO Urinary Pain Relief
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2018-04-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:59:14
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
OTC - PURPOSE SECTION
Purpose
Urinary tract analgesic
INDICATIONS & USAGE SECTION
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infection.
WARNINGS SECTION
Warnings
Please read insert for important precautions.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride
OTC - DO NOT USE SECTION
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
OTC - WHEN USING SECTION
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.
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- Adults and children 12 years and older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor.
- Children under 12: Do not use without consulting a doctor.
OTHER SAFETY INFORMATION
Other Information
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
- This product may stain soft contact lenses and other items if handled after touching tablets
- Store at room temperature (59°-86°F) in a dry place and protect from light
Tamper evident: Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.
INACTIVE INGREDIENT SECTION
Inactive ingredientsCorn starch, croscamellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide and talc.
OTC - QUESTIONS SECTION
Información y instrucciones en Español adjuntas
Distributed by i-Health, Inc. 55 Sebethe Drive, Cromwell, CT 06416
Country of origin: U.S.
Size and color of tablets may vary.
For questions, concerns, or to report an adverse event, call (800) 722-3476
HOW SUPPLIED
Product: 50090-1709
NDC: 50090-1709-0 2 TABLET in a BLISTER PACK / 15 in a BOX
Phenazopyridine Hydrochloride
Products#
Every source-derived product name is available through these pages.
- AZO Urinary Pain Relief
- Phenazopyridine Hydrochloride
- PHENAZOPYRIDINE
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- SHELLAC
- POVIDONE K30
- STARCH, CORN
- TALC
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-1709 | 50090-1709-0 |
| 49973-761 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENAZOPYRIDINE HYDROCHLORIDE | 0EWG668W17 | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SHELLAC | 46N107B71O | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 209fdf06-8ef2-418c-b130-9b82422c2bd0 | 844806f5-1e06-4ec4-959d-9e8fead044d6 | 2018-04-26 | Warnings | 209fdf06-8ef2-418c-b130-9b82422c2bd0 844806f5-1e06-4ec4-959d-9e8fead044d6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
