Label at a glance#

ProductPHENAZOPYRIDINE HYDROCHLORIDE

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

PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1094126	phenazopyridine HCl 95 MG Oral Tablet	PSN	3
1094126	phenazopyridine hydrochloride 95 MG Oral Tablet	SCD	3
1094126	phenazopyridine HCl 95 MG Oral Tablet	SY	3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2273-3	PHENAZOPYRIDINE HYDROCHLORIDE	30 in 1 BLISTER PACK	TABLET	30		3
68071-2273-3	PHENAZOPYRIDINE HYDROCHLORIDE	1 in 1 CARTON	TABLET	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2273	PHENAZOPYRIDINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240719_b11bdb87-4ebc-3a14-e053-2a95a90a7d73.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-076-44	EA - Each	49348-076	b1494833-d61f-440d-9bf0-fd0e544b2d76	1	2015-10-02

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

PHENAZOPYRIDINE HYDROCHLORIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SHELLAC
CROSCARMELLOSE SODIUM
SODIUM STARCH GLYCOLATE TYPE A CORN
LACTOSE
MAGNESIUM SILICATE
PHENAZOPYRIDINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-2273	68071-2273-3
49348-076

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SHELLAC	46N107B71O	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM SILICATE	9B9691B2N9	IACT
PHENAZOPYRIDINE HYDROCHLORIDE	0EWG668W17	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunmark Urinary Pain Relief	PHENAZOPYRIDINE HYDROCHLORIDE	Strategic Sourcing Services LLC	76653afb-7829-4fa4-acd0-aaac41ce0bf2	2024-12-18	Warnings	Exact identifier ndc (product): 49348-076
PHENAZOPYRIDINE HYDROCHLORIDE	PHENAZOPYRIDINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b11bdb87-4ebc-3a14-e053-2a95a90a7d73	2024-07-17	Warnings	Exact identifier ndc (package): 68071-2273-3 ndc (product): 68071-2273 ndc11 (package): 68071227303 spl id: 1d76957a-bafd-0eb0-e063-6294a90aaadd spl set id: b11bdb87-4ebc-3a14-e053-2a95a90a7d73

Reported adverse events (FAERS/openFDA)#

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