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#

ProductAZO Urinary Pain Relief
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure16 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

www.azoproducts.com

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1709

NDC: 50090-1709-0 2 TABLET in a BLISTER PACK / 15 in a BOX

Phenazopyridine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-170950090-1709-0
49973-761

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
209fdf06-8ef2-418c-b130-9b82422c2bd0844806f5-1e06-4ec4-959d-9e8fead044d62018-04-26WarningsExact identifier
spl id: 209fdf06-8ef2-418c-b130-9b82422c2bd0
spl set id: 844806f5-1e06-4ec4-959d-9e8fead044d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.