Urinary Pain Relief
FDA Label NDC 30142-757

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Urinary Pain Relief (NDC 30142-757). 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 other, active ingredient (in each tablet), purpose, uses, warnings, otc - do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

Active Ingredient (In Each Tablet)

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary tract analgesic

Uses

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

Otc - Do Not Use

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 HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

Otc - Pregnancy Or Breast Feeding

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

Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years and over: 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 years: Do not use without consulting a doctor

Other Information

  • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
  • This product may stain contact lenses and other items if handled after touching tablets.
  • Store at room temperature between 15°C -30°C (59°F -86°F) in a dry place and protect from light.

Inactive Ingredients

colloidal silicone dioxide, gum acacia extra pure, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate

Questions Or Comments?

call 1-800-632-6900

Principal Display Panel - 95 Mg Tablet Blister Pack Carton

*Compare to active ingredient of AZO® URINARY
PAIN RELIEF MAXIMUM STRENGTH *see back panel
NDC XXXXX-XXX-XX

Urinary
Pain Relief

Phenazopyridine
Hydrochloride 95 mg

FAST RELIEF
FOR URINARY
DISCONFORT

actual
size

30 TABLETS

Principal Display Panel (95 mg Tablet Blister Pack Carton)

Principal Display Panel (95 mg Tablet Blister Pack Carton)

* Please review the disclaimer below.