FDA.reportPublic FDA data

Uristat Ultra

Manufacturer
Medtech Products Inc.
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:40:34

Label at a glance#

ProductUristat Ultra
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure11 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

URISTAT ® ULTRA

Phenazopyridine Hydrochloride  99.5 mg

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine hydrochloride 99.5 mg

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
  • experience a yellowish tinge of skin or eyes
  • experience fevers chills, back pain or bloody urine

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

OTHER SAFETY INFORMATION

  • 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

citric acid, artificial & natural cranberry flavor, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silica, starch, and sucralose.

 Questions?

OTC - QUESTIONS SECTION

1-800-344-7239  Uristat.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

URISTAT® ULTRA with Cranberry flavored coating

UTI Pain Relief Tablets

Phenazopyridine Hydrochloride  99.5 mg

30 Urinary Pain Relief Tablets

PRINCIPAL DISPLAY PANEL URISTAT® ULTRA with Cranberry flavored coating UTI Pain Relief Tablets Phenazopyridine Hydrochloride 99.5 mg 30 Urinary Pain Relief TabletsPRINCIPAL DISPLAY PANEL URISTAT® ULTRA with Cranberry flavored coating UTI Pain Relief Tablets Phenazopyridine Hydrochloride 99.5 mg 30 Urinary Pain Relief Tablets

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RISTAT® ULTRA with Cranberry flavored coating

UTI Relief PAK™

Phenazopyridine Hydrochloride  99.5 mg

1 UTI Test Strip and 12 Urinary Pain Relief Tablets

PRINCIPAL DISPLAY PANEL RISTAT® ULTRA with Cranberry flavored coating UTI Relief PAK™ Phenazopyridine Hydrochloride 99.5 mg 1 UTI Test Strip and 12 Urinary Pain Relief TabletsPRINCIPAL DISPLAY PANEL RISTAT® ULTRA with Cranberry flavored coating UTI Relief PAK™ Phenazopyridine Hydrochloride 99.5 mg 1 UTI Test Strip and 12 Urinary Pain Relief Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN4
2000033URISTAT ULTRA 99.5 MG Oral TabletPSN4
2000033phenazopyridine hydrochloride 99.5 MG Oral Tablet [Uristat]SBD4
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD4
1094147phenazopyridine HCl 99.5 MG Oral TabletSY4
2000033Uristat Ultra 99.5 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-105-12Uristat Ultra12 in 1 BLISTER PACKTABLET124
63029-105-12Uristat Ultra1 in 1 CARTONTABLET14
63029-105-30Uristat Ultra10 in 1 BLISTER PACKTABLET104
63029-105-30Uristat Ultra3 in 1 CARTONTABLET34

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-10563029-105-12, 63029-105-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENAZOPYRIDINE HYDROCHLORIDE0EWG668W17ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-12-18full-release2026-06-01 00:43:33

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
Uristat UltraPHENAZOPYRIDINE HYDROCHLORIDEMedtech Products Inc.c705185f-4908-451e-993b-b0b8a73f03922025-10-23WarningsExact identifier
ndc (package): 63029-105-12
ndc (package): 63029-105-30
ndc (product): 63029-105
ndc11 (package): 63029010512
ndc11 (package): 63029010530
spl id: 14db261b-912d-4675-b681-4162d783ae1d
spl set id: c705185f-4908-451e-993b-b0b8a73f0392

Reported adverse events (FAERS/openFDA)#

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