GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:46

Label at a glance#

ProductGOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

• Adults and children 12 years and over: 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 years: Do not use without consulting a doctor

Storage and handling

Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests. • This product may stain contact...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine Hydrochloride 99.5 mg

Purpose

OTC - PURPOSE SECTION

Urinary tract analgesic

Use

INDICATIONS & USAGE SECTION

Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Treatment should not exceed 2 days; see Directions.

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

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

Ask a doctor before use if you have • liver or kidney disease
• allergies to foods, preservatives or dyes • had a hypersensitive reaction to Phenazopyridine Hydrochloride

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years and over: 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 years: Do not use without consulting a doctor

Other information

STORAGE AND HANDLING SECTION

Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
• This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests.
• This product may stain contact lenses and other items if handled after touching tablets.
• Store at room temperature between 20°C-25°C (68°F -77°F) in a dry place and protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicone dioxide, gum acacia extra pure, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday - Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in AZO Urinary Pain Relief® Maximum Strength*

Maximum strength UTI pain reliever available without a prescription†

Helps provide relief for:urinary pain and burning

†Among our over the counter urinary pain relief products

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Distributed by: Strive Pharmaceuticals, Inc.
East Brunswick, NJ 08816

PRODUCT OF INDIA

*This product is not manufactured or distributed by i-Health Inc., distributor of AZO Urinary Pain Relief®.

WARNING: This product can expose you to Phenazopyridine Hydrochloride, which is known to the state of California to cause cancer. For more information, visit www.p65warnings.ca.gov

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Good Remedies Maximum Strength Urinary Pain Relief CapletGood Remedies Maximum Strength Urinary Pain Relief Caplet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN2
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD2
1094147phenazopyridine HCl 99.5 MG Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-178-08GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet1 in 1 CARTONTABLET, FILM COATED12
70692-178-08GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet8 in 1 BLISTER PACKTABLET, FILM COATED82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-178GOOD REMEDIES MAXIMUM STRENGTH URINARY PAIN RELIEF CAPLET (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET, FILM COATED [STRIVE PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250112_269fa921-f4c4-16e7-e063-6394a90a0cbb.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-17870692-178-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD REMEDIES Maximum Strength Urinary Pain Relief CapletPHENAZOPYRIDINE HYDROCHLORIDEStrive Pharmaceuticals Inc.269fa921-f4c4-16e7-e063-6394a90a0cbb2025-01-06WarningsExact identifier
ndc (package): 70692-178-08
ndc (product): 70692-178
ndc11 (package): 70692017808
spl id: 3b8052c0-6936-4d15-82f6-885f083694a4
spl set id: 269fa921-f4c4-16e7-e063-6394a90a0cbb

Reported adverse events (FAERS/openFDA)#

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