TopCare Urinary Pain Relief

Manufacturer
TOPCO ASSOCIATES LLC | Reese Pharmaceutical Co
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:44:34

Label at a glance#

ProductTopCare Urinary Pain Relief
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine Hydrochloride 95 mg

Purpose

OTC - PURPOSE SECTION

Urinary Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warning

WARNINGS SECTION

Do not exceed recommended dosage

Ask 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

■ 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

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 the 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.

Directions

DOSAGE & ADMINISTRATION SECTION


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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

lactose, magnesium silicate, magnesium stearate, microcrystalline

cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch,

croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton
image of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094126phenazopyridine HCl 95 MG Oral TabletPSN7
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCD7
1094126phenazopyridine HCl 95 MG Oral TabletSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-040-30TopCare Urinary Pain Relief30 in 1 BLISTER PACKTABLET307
36800-040-30TopCare Urinary Pain Relief1 in 1 CARTONTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-040TOPCARE URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 2 package rows20241220_2d272b96-c676-4ed8-aa08-df2d41a2ef41.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-040-30EA - Each36800-0400d1517fb-a3ac-4922-a058-d1690cbc098712024-04-05

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-04036800-040-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
TopCare Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDETOPCO ASSOCIATES LLC2d272b96-c676-4ed8-aa08-df2d41a2ef412024-12-18WarningsExact identifier
ndc (package): 36800-040-30
ndc (product): 36800-040
ndc11 (package): 36800004030
spl id: 1666a619-d61a-4b2e-a8c9-997287798d4d
spl set id: 2d272b96-c676-4ed8-aa08-df2d41a2ef41

Reported adverse events (FAERS/openFDA)#

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