Preferred Urinary Pain Relief

Manufacturer
NuCare Pharmaceuticals,Inc. | NuCare Pharmceuticals,Inc.
Effective date
2021-02-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:52:27

Label at a glance#

ProductPreferred 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

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4417-32024-06-10C16284748780-1ba0f9c33-43ce-a910-e053-dadaa90a0b85DRUG FACTS
68071-4417-32023-01-30C16284748780-1ba0f9c33-43ce-a910-e053-dadaa90a0b85DRUG FACTS
68071-4417-32021-02-16C16284748780-1ba0f9c33-43ce-a910-e053-dadaa90a0b85DRUG FACTS
68071-4417-32021-01-29C16284748780-1ba0f9c33-43ce-a910-e053-dadaa90a0b85DRUG FACTS

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
68071-441768071-4417-3
10956-551

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 · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preferred Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEReese Pharmaceutical Co668f59c9-e543-49fc-96f5-a8077f7605292024-12-18WarningsExact identifier
ndc (product): 10956-551
1a8c2358-eada-a2b9-e063-6294a90a3cb46b693369-4ba4-277f-e053-2a91aa0a1b3e2024-06-10WarningsExact identifier
spl set id: 6b693369-4ba4-277f-e053-2a91aa0a1b3e

Reported adverse events (FAERS/openFDA)#

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