Uti Pain Relief Tablet
FDA Label NDC 73436-2441

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cadence Health for the product Uti Pain Relief (NDC 73436-2441). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use:, ask a doctor before use if you have:, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Phenazopyridine Hydrochloride 99.5 mg

Purpose

Urinary tract analgesic

Uses

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

Warnings

Do not exceed recommended dosage

Do Not Use:

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

Ask A Doctor Before Use If You Have:

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

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
    • 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

ask a health professional before use.

Keep Out Of Reach Of Children

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

Directions

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

  • 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

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

Manufactured For

Cadence OTC, Oakland, CA 94612

Questions Or Comments:

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)

Carton (Carton)

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