AZO Urinary Pain Relief

Manufacturer: i-Health, Inc. | Contract Pharmacal Corp.
Effective date: 2020-12-12
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 23:01:21

Label at a glance#

ProductAZO Urinary Pain Relief

Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE

Label structure15 sections

Contacts and useful links#

PhoneLabel contact(800) 722-3476

Websitewww.azoproducts.com

www.azoproducts.com

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

OTC - PURPOSE SECTION

Purpose

Urinary tract analgesic

INDICATIONS & USAGE SECTION

Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infection.

WARNINGS SECTION

Warnings

Please read insert for important precautions.

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 - DO NOT USE SECTION

Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

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 breastfeeding, ask a health professional before use. A pregnancy test and consultation with a health 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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions

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 SAFETY INFORMATION

Other Information

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 (59°-86°F) in a dry place and protect from light

Tamper evident: Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.

INACTIVE INGREDIENT SECTION

Inactive ingredientsCorn starch, croscamellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide and talc.

OTC - QUESTIONS SECTION

Información y instrucciones en Español adjuntas

Distributed by i-Health, Inc. 55 Sebethe Drive, Cromwell, CT 06416

Country of origin: U.S.

Size and color of tablets may vary.

For questions, concerns, or to report an adverse event, call (800) 722-3476

www.azoproducts.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fast Relief for Urinary Pain

AZO

Urinary Pain Relief

VALUE SIZE

RELIEVES PAIN, BURNING & URGENCY
TARGETS THE SOURCE OF PAIN

#1 MOST TRUSTED BRAND

30 Tablets

95 mg Phenazopyridine Hydrochloride

Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PHENAZOPYRIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	0EWG668W17	1
PHENAZOPYRIDINE	ACTIVE MOIETY	K2J09EMJ52	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

AZO Urinary Pain Relief
Phenazopyridine Hydrochloride
PHENAZOPYRIDINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SHELLAC
POVIDONE K30
STARCH, PREGELATINIZED CORN
TALC
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49973-761	49973-761-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PHENAZOPYRIDINE HYDROCHLORIDE	0EWG668W17	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SHELLAC	46N107B71O	IACT
POVIDONE K30	U725QWY32X	IACT
STARCH, PREGELATINIZED CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 248 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	SOLUTION / OPHTHALMIC		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	POWDER / ORAL		378 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, EXTENDED RELEASE / ORAL	75.01 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, FILM COATED / ORAL	4.4 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	POWDER, FOR SUSPENSION / ORAL		257 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE / ORAL		540 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL		392 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	INJECTION / INTRAMUSCULAR	1 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, DELAYED RELEASE PELLETS / ORAL		178 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	45 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, EXTENDED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, DELAYED RELEASE / ORAL		227 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TROCHE / ORAL		50 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TROCHE / ORAL		175 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FOR SUSPENSION / ORAL		1875 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE / ORAL	34.48 mg		Exact identifier — unii candidate 13 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d101964d-3a42-d61d-e053-2995a90a4335			b2c6bb64-bb81-413c-8a6b-0420d2573ab6	2021-11-17	Warnings	Exact identifier spl set id: b2c6bb64-bb81-413c-8a6b-0420d2573ab6

Reported adverse events (FAERS/openFDA)#

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