FDA.reportPublic FDA data

Sunmark Urinary Pain Relief Maximum Strength

Manufacturer
Bryant Ranch Prepack
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:00

Label at a glance#

ProductSunmark Urinary Pain Relief Maximum Strength
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

PURPOSE

OTC - PURPOSE SECTION

PHENAZOPYRIDINE HYDROCHLORIDE                     URINARY ANALGESIC

WARNINGS

WARNINGS SECTION

DO NOT EXCEED RECOMMENDED DOSAGE

ASK DOCTOR

OTC - ASK DOCTOR SECTION

ASK DOCTOR BEFORE USE

IF YOU HAVE KIDNEY DISEASE

ALLERGIES TO FOODS,PRESERVATIVES OR DYES

HAD A HYPERSENSITIVE REACTION TO PHENAZOPYRIDINE

WHEN USING

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ASK A HEALTH PROFESSIONAL BEFORE US

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IN CASE OF OVERDOSE ,GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

pharmaceutical glaze, and sodium starch glycolate.

DOSAGE & ADMINISTRATION

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.

HOW SUPPLIED

How Supplied Section

NDC: 71335-1661-1: 6 Tablets in a BOTTLE

NDC: 71335-1661-2: 12 Tablets in a BOTTLE

NDC: 71335-1661-3: 36 Tablets in a BOTTLE

NDC: 71335-1661-4: 20 Tablets in a BOTTLE

NDC: 71335-1661-5: 10 Tablets in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phenazopyridine Hcl 97.5mg Tablet

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094357phenazopyridine HCl 97.5 MG Oral TabletPSN2
1094357phenazopyridine hydrochloride 97.5 MG Oral TabletSCD2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1661-12024-01-30C16284748780-11030e364-f9f0-111a-e063-dadaa90a10e2Drug Facts
71335-1661-22024-01-30C16284748780-11030e364-f9f0-111a-e063-dadaa90a10e2Drug Facts
71335-1661-32024-01-30C16284748780-11030e364-f9f0-111a-e063-dadaa90a10e2Drug Facts
71335-1661-42024-01-30C16284748780-11030e364-f9f0-111a-e063-dadaa90a10e2Drug Facts
71335-1661-52024-01-30C16284748780-11030e364-f9f0-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1661-1Sunmark Urinary Pain Relief Maximum Strength6 in 1 BOTTLETABLET62
71335-1661-2Sunmark Urinary Pain Relief Maximum Strength12 in 1 BOTTLETABLET122
71335-1661-3Sunmark Urinary Pain Relief Maximum Strength36 in 1 BOTTLETABLET362
71335-1661-4Sunmark Urinary Pain Relief Maximum Strength20 in 1 BOTTLETABLET202
71335-1661-5Sunmark Urinary Pain Relief Maximum Strength10 in 1 BOTTLETABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1661SUNMARK URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]2Legacy NDC, 5 package rows20220205_6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-941-01EA - Each49348-941b0f4efe2-281c-430c-abb6-3cd393b22b1612022-06-06
49348-941-02EA - Each49348-94146f92040-f39b-4580-a3e4-baf6ee67231512012-07-24

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-166171335-1661-1, 71335-1661-2, 71335-1661-3, 71335-1661-4, 71335-1661-5
49348-941

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENAZOPYRIDINE HYDROCHLORIDE0EWG668W17ACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MAGNESIUM STEARATE70097M6I30IACT

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
6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e2021-12-28WarningsExact identifier
spl id: 6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e
spl set id: 6f24b86c-ac61-4c4b-a7ba-86f875dd4d3e

Reported adverse events (FAERS/openFDA)#

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