UTI PAIN RELIEF - Cadence Health

Manufacturer
Cadence Health
Effective date
2026-04-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:52:49

Label at a glance#

ProductUTI PAIN RELIEF
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions

Dosage and administration

Adults and children 12 years and over: Take 2 tablets 3 times daily with a full glass of water, with or after meals as needed. Do not use for more than 2 days (12 tablets) without consulting a doctor. Children under 12 years: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine Hydrochloride 99.5 mg

Purpose

OTC - PURPOSE SECTION

Urinary tract analgesic

Uses

INDICATIONS & USAGE SECTION

Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

Do Not Use:

OTC - DO NOT USE SECTION

if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • kidney disease
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to phenazopyridine

When using this product:

OTC - WHEN USING SECTION

  • 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:

OTC - STOP USE SECTION

  • your symptoms last for more than 2 days
  • you suspect you are having an adverse reaction to the medication
  • long-term administration of phenazopyridine hydrochloride 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.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of an overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over:

  • Take 2 tablets 3 times daily with a full glass of water, with or after meals as needed.
  • Do not use for more than 2 days (12 tablets) without consulting a doctor.

Children under 12 years:

  • consult a doctor.

Other information

OTHER SAFETY INFORMATION

  • this product may stain contact lenses
  • this product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
  • store at room temperature between 15-30°C (59-86°F) in a dry place and protect from light
  • Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open and damaged

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc, triacetin.

MANUFACTURED FOR

SPL UNCLASSIFIED SECTION

Cadence OTC, Oakland, CA 94612

Questions or comments:

OTC - QUESTIONS SECTION

Call 1-877-862-7455 or visit us at cadenceotc.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CadenceOTC

UTI
PAIN RELIEF


Maximum Strength, fast relief
from UTI pain and burning

99.5 MG PHENAZOPYRIDINE HYDROCHLORIDE

2 day supply
12 tablets

WARNING:This product can expose you to
phenazopyridine hydrochloride, which is known to
the state of California to cause cancer. For more
information visit www.P65Warnings.ca.gov

CSSMAXCAD Rev 12/25

Carton
Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN2
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD2
1094147phenazopyridine HCl 99.5 MG Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73436-2441-2UTI PAIN RELIEF12 in 1 BLISTER PACKTABLET122
73436-2441-2UTI PAIN RELIEF1 in 1 CARTONTABLET12

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73436-244173436-2441-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UTI EMERGENCY RELIEFMETHENAMINE, SODIUM SALICYLATE, AND PHENAZOPYRIDINE HYDROCHLORIDE KITCADENCE HEALTH, INC.3a923df5-15ed-404d-8741-33a9793cb7f52026-04-06WarningsExact identifier
ndc (package): 73436-2441-2
ndc11 (package): 73436244102
UTI PAIN RELIEFPHENAZOPYRIDINE HYDROCHLORIDECadence Health7fa8e314-025c-46c2-b97a-91c4f385e5652026-04-06WarningsExact identifier
ndc (package): 73436-2441-2
ndc (product): 73436-2441
ndc11 (package): 73436244102
spl id: 4ece86b2-06de-2cd8-e063-6294a90a5a7c
spl set id: 7fa8e314-025c-46c2-b97a-91c4f385e565

Reported adverse events (FAERS/openFDA)#

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