FDA.reportPublic FDA data

UristatUTI Relief Pak

Manufacturer
Liberty Pharmaceuticals, Inc.
Effective date
2016-10-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:47:41

Label at a glance#

ProductUristatUTI Relief Pak UTI Relief Pak
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Phenazopyridine hydrochloride 95mg

Purpose

OTC - PURPOSE SECTION

Urinary analgesic

Use

INDICATIONS & USAGE SECTION

fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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 (1-800-222-1222) right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • This product may stain contact lenses
  • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
  • Long term administration of phenazopyridine HCl 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
  • Store at 20º-25º C (68º-77º F) in a dry place and protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, and talc

Questions?

OTC - QUESTIONS SECTION

Call 1-800-344-7239 or visit our website at www.Uristat.com

©2015 Distributed by:
Insight Pharmaceuticals LLC
Tarrytown, NY 10591
A Prestige Brands Company

Repackaged By:

Aidarex Pharmaceuticals, LLC.

Corona, CA 92882

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phenazopyridine Hydrochloride 95mg

IMAGE LABEL
IMAGE LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094126phenazopyridine HCl 95 MG Oral TabletPSN2
1094151Uristat 95 MG Oral TabletPSN2
1094151phenazopyridine hydrochloride 95 MG Oral Tablet [Uristat]SBD2
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCD2
1094126phenazopyridine HCl 95 MG Oral TabletSY2
1094151Uristat 95 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-8065-012020-01-31C16284748780-19d75b9d1-11af-f424-e053-dadaa90a57ceUristat
0440-8065-052020-01-31C16284748780-19d75b9d1-11af-f424-e053-dadaa90a57ceUristat
0440-8065-302020-01-31C16284748780-19d75b9d1-11af-f424-e053-dadaa90a57ceUristat
0440-8065-692020-01-31C16284748780-19d75b9d1-11af-f424-e053-dadaa90a57ceUristat

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-8065-01UristatUTI Relief PakUTI Relief Pak100 in 1 BOTTLETABLET1002
0440-8065-05UristatUTI Relief PakUTI Relief Pak500 in 1 BOTTLETABLET5002
0440-8065-30UristatUTI Relief PakUTI Relief Pak30 in 1 BOTTLETABLET302
0440-8065-69UristatUTI Relief PakUTI Relief Pak96 in 1 BLISTER PACKTABLET962

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-8065URISTATUTI RELIEF PAK UTI RELIEF PAK (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 4 package rows20161019_f6e24576-e90c-451e-b2f8-261b61a00fcc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-8065-69EA - Each0440-8065ade4c46d-c71b-4208-addd-1a5e2aa64eee12016-11-08

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0440-80650440-8065-01, 0440-8065-05, 0440-8065-30, 0440-8065-69
63736-961

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENAZOPYRIDINE HYDROCHLORIDE0EWG668W17ACTIB
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SHELLAC46N107B71OIACT

Source Document#

Source XML · Source PDF

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
5a4f76e9-f914-4e6f-b218-abf3ab5460c6f6e24576-e90c-451e-b2f8-261b61a00fcc2016-10-12WarningsExact identifier
spl id: 5a4f76e9-f914-4e6f-b218-abf3ab5460c6
spl set id: f6e24576-e90c-451e-b2f8-261b61a00fcc

Reported adverse events (FAERS/openFDA)#

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