DRUG FACTS

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-11 05:10:22

Label at a glance#

ProductPreferred 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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength Urinary Pain Relief
Maximum Strength Urinary Pain Relief

68788-7778-1

Relabeled By: Preferred Pharmaceuticals Inc.

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 12813790FA8638C-E3E0-4BBF-9101-842E5D8736D6-00.jpg
Data codeData Matrix**100825*0FA8638C-E3E0-4BBF-9101-842E5D8736D6-00.jpg

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
68788-777868788-7778-3
10956-210

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preferred Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0fa8638c-e3e0-4bbf-9101-842e5d8736d62026-06-04WarningsExact identifier
ndc (package): 68788-7778-3
ndc (product): 68788-7778
ndc11 (package): 68788777803
spl id: 0fa8638c-e3e0-4bbf-9101-842e5d8736d6
spl set id: 0fa8638c-e3e0-4bbf-9101-842e5d8736d6
Preferred Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEReese Pharmaceutical Co4436632a-e848-4ba9-9c78-43abb365c4242024-12-18WarningsExact identifier
ndc (product): 10956-210

Reported adverse events (FAERS/openFDA)#

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