AZO

Manufacturer: i-Health, Inc.
Effective date: 2026-01-05
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:31:13

Label at a glance#

ProductAZO

Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE

Label structure10 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 analgesic

INDICATIONS & USAGE SECTION

UseRelief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

WARNINGS SECTION

Warnings Please read insert for important precautions.

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

Caution:Do not use this product 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 doctor

your symptoms last for more than 2 days
you suspect you are having an adverse reaction to the medication.

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 or 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.

GENERAL PRECAUTIONS SECTION

Other Inf ormation

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: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.

INACTIVE INGREDIENT SECTION

Inactive ingredientsmicrocrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate. May also contain corn starch.

OTC - QUESTIONS SECTION

Distributed by i-Health, Inc.

25 Bacon Road, Enfield, CT 06082

Made in India.

Most Trusted Brand based on Nielsen data through 3/23/2013.

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

www.azoproducts.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AZO

Urinary Pain Relief

Relieves pain, burning & urgency
Targets the source of pain

#1 Most Trusted Brand

Tablets

95 mg Phenazopyridine Hydrochloride

AZO UPR Label Combined

AZO UPR 95

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1094192	Azo Urinary Pain Relief 95 MG Oral Tablet	PSN	8
1094126	phenazopyridine HCl 95 MG Oral Tablet	PSN	8
1094192	phenazopyridine hydrochloride 95 MG Oral Tablet [Azo Urinary Pain Relief]	SBD	8
1094126	phenazopyridine hydrochloride 95 MG Oral Tablet	SCD	8
1094192	Azo Urinary Pain Relief 95 MG Oral Tablet	SY	8
1094126	phenazopyridine HCl 95 MG Oral Tablet	SY	8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49973-301-30	AZO	15 in 1 BOX	TABLET	15	8
49973-301-30	AZO	2 in 1 BLISTER PACK	TABLET	2	8
49973-301-31	AZO	15 in 1 BOX	TABLET	15	8
49973-301-31	AZO	2 in 1 BLISTER PACK	TABLET	2	8
49973-301-32	AZO	1 in 1 BOX	TABLET	1	8
49973-301-32	AZO	18 in 1 BLISTER PACK	TABLET	18	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49973-301-31	EA - Each	49973-301	188f7be8-bc47-4830-b185-86c345159e86	1	2019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Phenazopyridine Hydrochloride	ACTIVE INGREDIENT	0EWG668W17	3
Phenazopyridine	ACTIVE MOIETY	K2J09EMJ52	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	3

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

AZO
Urinary Pain Relief
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
HYPROMELLOSES
POVIDONE, UNSPECIFIED
CROSCARMELLOSE SODIUM
POLYETHYLENE GLYCOL, UNSPECIFIED
CARNAUBA WAX
MAGNESIUM STEARATE
PHENAZOPYRIDINE HYDROCHLORIDE
PHENAZOPYRIDINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49973-301	49973-301-31, 49973-301-30, 49973-301-32

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
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
PHENAZOPYRIDINE HYDROCHLORIDE	0EWG668W17	ACTIB

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 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 4 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
AZO	URINARY PAIN RELIEF	i-Health, Inc.	3d0298b7-eaec-488b-9cab-19af4614ff53	2026-01-05	Warnings	Exact identifier ndc (package): 49973-301-32 ndc (package): 49973-301-30 ndc (package): 49973-301-31 ndc (product): 49973-301 ndc11 (package): 49973030131 ndc11 (package): 49973030132 ndc11 (package): 49973030130 spl id: 47a4fa0f-9c93-6286-e063-6394a90aa070 spl set id: 3d0298b7-eaec-488b-9cab-19af4614ff53

Reported adverse events (FAERS/openFDA)#

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