Urinary Pain Relief

Manufacturer: Strategic Sourcing Services LLC
Effective date: 2019-09-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:12:34

Label at a glance#

ProductUrinary Pain Relief

Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

for temporary relief of urinary pain burning urgency frequency associated with urinary tract infection

Dosage and administration

adults and children 12 years of age and over : take 2 tablets 3 times per day with or after meals as needed. Take with a full glass of water. children under 12 years of age : consult a doctor

Contacts and useful links#

Websitewww.sunmarkbrand.com

www.sunmarkbrand.com

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine Hydrochloride 95 mg

Purpose

OTC - PURPOSE SECTION

Urinary analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of

urinary pain
burning
urgency
frequency associated with urinary tract infection

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

for more than 2 days without consulting a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

kidney disease
hepatic or renal problems
allergies to foods, preservatives, or dyes
previously exhibited hypersensitivity to Phenazopyridine.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persists for more than 2 days
yellowish tinge of skin or sclera occurs

When using this product

OTC - WHEN USING SECTION

stomach upset may occur
a harmless reddish- orange color will be produced in the urine and may stain fabric
staining of the contact lenses may also occur

If pregnant or breast- feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over: take 2 tablets 3 times per day with or after meals as needed. Take with a full glass of water.
children under 12 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

store at controlled room temperature 15°-30°C (59°-86°F)
do not use if cellophane packet is torn or open
*This product is not manufactured or distributed by Amerifit Brands, Inc., the distributor of AZO Standard®.

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze and sodium starch glycolate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to AZO STANDARD® active ingredient*

Urinary Pain Relief

Phenazopyridine HCl

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Another quality product Distributed by McKesson

One post street, San Franciso, CA 94104

Money back guarantee

Please visit us at www.sunmarkbrand.com

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-364-44	EA - Each	49348-364	5a1b248a-ff34-4aaf-96e9-b8b05d7b8a33	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PHENAZOPYRIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	0EWG668W17	1
PHENAZOPYRIDINE	ACTIVE MOIETY	K2J09EMJ52	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	1

Products#

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

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

Urinary Pain Relief
Phenazopyridine Hydrochloride
PHENAZOPYRIDINE
ANHYDROUS LACTOSE
MAGNESIUM SILICATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49348-364	49348-364-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PHENAZOPYRIDINE HYDROCHLORIDE	0EWG668W17	ACTIB
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
MAGNESIUM SILICATE	9B9691B2N9	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SHELLAC	46N107B71O	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	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 2 · 111 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / SUBLINGUAL	128 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 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
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	CAPSULE, EXTENDED RELEASE / ORAL		869 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		316 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	CAPSULE, DELAYED RELEASE / ORAL		360 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	CAPSULE / ORAL	40 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET / SUBLINGUAL	1.2 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, COATED PELLETS / ORAL		456 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	POWDER, FOR SUSPENSION / ORAL		469 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	SUSPENSION / ORAL	15.69 mg/5ml		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	SOAP / TOPICAL	0.33 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, DELAYED RELEASE / ORAL		1083 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	FILM / SUBLINGUAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, COATED / ORAL		560 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 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
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET, COATED / ORAL	29.03 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, EXTENDED RELEASE / ORAL	75.01 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET, CHEWABLE / ORAL	30 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, ORALLY DISINTEGRATING / ORAL		410 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FOR SUSPENSION / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		375 mg	Exact identifier — unii candidate 21 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, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	CAPSULE / ORAL		2490 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, CHEWABLE / ORAL		2850 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	25 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM SILICATE	MAGNESIUM SILICATE	9B9691B2N9	TABLET / ORAL	10 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, COATED PELLETS / ORAL	29 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 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
2704d4c4-3214-4a67-80b3-233ae6fabab2			b73f9b1f-aa6f-468f-880e-a7fa4bcf930b	2019-09-10	Warnings	Exact identifier spl id: 2704d4c4-3214-4a67-80b3-233ae6fabab2 spl set id: b73f9b1f-aa6f-468f-880e-a7fa4bcf930b

Reported adverse events (FAERS/openFDA)#

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