Maximum Strength Urinary Pain Relief

Manufacturer
Advanced Rx LLC | INVAHEALTH INC.
Effective date
2024-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:06

Label at a glance#

ProductMaximum Strength Urinary Pain Relief
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

• Adults and children 12 years and older: 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

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

Use

INDICATIONS & USAGE SECTION

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:

• kidney disease

• allergies to foods, preservatives or dyes   

• had a hypersensitive reaction to Phenazopyridine Hydrochloride

Do not useif you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

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.  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 SECTION

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

Other information

OTHER SAFETY 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 (59ºF -86ºF) in a dry place and protect from light.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years and older: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

Inactive ingredients

INACTIVE INGREDIENT SECTION

pregelatinized starch, microcrystalline cellulose, maize (corn) strach, povidone, croscarmellose sodium, magnesium stearate, colloidal silicone dioxide, hydroxypropyl methylcellulose, polyethylene glycol.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-630-8895

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in  AZO Urinary Pain Relief ®Maximum Strength*  

NDC 80513-517-72

Maximum Strength Urinary Pain Relief

99.5 mg Phenazopyridine Hydrochloride

#1 DOCTOR RECOMMENDED OTC INGREDIENT FOR UTI PAIN

TEMPORARY RELIEF OF URINARY PAIN, BURNING & URGENCY

Urinary Analgesic

72 Tablets

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Size and color of tablet may very.

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

*This product is not manufactured or distributed by I-Health, Inc., owner of the registered trademark of AZO Urinary Pain Relief ®Maximum Strength

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN USA

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN1
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD1
1094147phenazopyridine HCl 99.5 MG Oral TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-517-72Maximum Strength Urinary Pain Relief72 in 1 BOTTLETABLET721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-517MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [ADVANCED RX LLC]1Current NDC, 1 package rows20240625_a10464cf-36b2-460f-b31c-2e0edee3e4cf.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80513-51780513-517-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEAdvanced Rx LLCa10464cf-36b2-460f-b31c-2e0edee3e4cf2024-05-01WarningsExact identifier
ndc (package): 80513-517-72
ndc (product): 80513-517
ndc11 (package): 80513051772
spl id: 1b87f423-20e1-743e-e063-6294a90aaa03
spl set id: a10464cf-36b2-460f-b31c-2e0edee3e4cf

Reported adverse events (FAERS/openFDA)#

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