Nuvicare-Urinary Pain Relief Maximum Strength

Manufacturer
NUVICARE LLC
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-07 01:01:02

Label at a glance#

ProductNuvicare-Urinary Pain Relief Maximum Strength
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure15 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: 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 use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ kidney disease

■ allergies to foods, preservatives or dyes

■ had a hypersensitive reaction to Phenazopyridine Hydrochloride.

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.

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use. A pregnancy test and consultation with a healthcare 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 (1-800-222-1222) right away.

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: Do not use without consulting a doctor.

Other information

OTHER SAFETY INFORMATION

WARNING:

■ This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer

■ This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests

■This product may stain soft contact lenses and other items if handled after touching tablets

■Store at room temperature (59º-86ºF) in a dry place and protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.

Questions or comments?

OTC - QUESTIONS SECTION

Call +1 (877) 413 1632 or email: support@nuvicare.com

SPL UNCLASSIFIED SECTION

†This product is neither manufactured nor distributed by i-Health, Inc., the distributor of AZO Urinary Pain Relief®
Maximum Strength.
Distributed by: Nuvicare LLC., Brooklyn, NY 11211, U.S.A.
www.nuvicare.com

NDC 84324-042-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L205-00 NC Urinary Maximum Pain ReliefL205-00 NC Urinary Maximum Pain Relief

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
84324-04284324-042-01

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
Nuvicare-Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDENUVICARE LLC5fe4e4dc-f1c4-4617-b6a6-6ea16a63abfe2026-08-03WarningsExact identifier
ndc (package): 84324-042-01
ndc (product): 84324-042
ndc11 (package): 84324004201
spl id: 373f0821-0e11-4eeb-968a-f592f43ae8c7
spl set id: 5fe4e4dc-f1c4-4617-b6a6-6ea16a63abfe

Reported adverse events (FAERS/openFDA)#

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