Sunmark Maximum Strength Urinary Pain Relief

Manufacturer
Strategic Sourcing Services LLC | Reese Pharmaceutical Co
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:58

Label at a glance#

ProductSunmark Maximum Strength Urinary Pain Relief
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure12 sections

Dosage and administration

■ adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ children under 12 years: consult a doctor ■ Do not use for more than 2 days (12 tablets) 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 Analgesic

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

■ kidney disease
■ allergies to food, 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 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 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 right away.

Use

INDICATIONS & USAGE SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.

Directions

DOSAGE & ADMINISTRATION SECTION


■ adults and children 12 years and over:
take 2 tablets 3 times daily with a full glass of water, with or after meals as needed

■ children under 12 years: consult a doctor

■ Do not use for more than 2 days (12 tablets) without consulting a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN4
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD4
1094147phenazopyridine HCl 99.5 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-0078-1Sunmark Maximum Strength Urinary Pain Relief1 in 1 CARTONTABLET14
70677-0078-1Sunmark Maximum Strength Urinary Pain Relief12 in 1 BLISTER PACKTABLET124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0078SUNMARK MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241220_cbc5de43-0f89-4e71-a764-749ef0ba2dfa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0078-1EA - Each70677-00783d88648b-6f32-4b92-8806-949b7c7e0fd112021-04-08

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-007870677-0078-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
Sunmark Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrategic Sourcing Services LLCcbc5de43-0f89-4e71-a764-749ef0ba2dfa2024-12-18WarningsExact identifier
ndc (package): 70677-0078-1
ndc (product): 70677-0078
ndc11 (package): 70677007801
spl id: 159490d5-3153-4318-8cef-3e8261558c95
spl set id: cbc5de43-0f89-4e71-a764-749ef0ba2dfa

Reported adverse events (FAERS/openFDA)#

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