DRUG FACTS

Manufacturer
Redpharm Drug
Effective date
2026-10-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-13 04:03:43

Label at a glance#

ProductFoster and Thrive Neighbor Pharmacy Urinary Pain Relief
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure13 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 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed ■ Children under 12 years: 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

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

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  

Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

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 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION


■ Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12 years:consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor

Other Information

OTHER SAFETY INFORMATION


■ this product may stain contact lenses
■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light

Inactive Ingredients

INACTIVE INGREDIENT SECTION

lactose, corn starch, croscarmellose sodium, microcrystalline

cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, 

pregelatinized starch, silicon dioxide, talc, and triacetin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton
image of carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1229-1EA - Each70677-1229db64f4a7-4f96-4fca-9263-b66fffca34e012024-10-04

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-233967296-2339-3
70677-1229

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Foster and Thrive Neighbor Pharmacy Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEStrategic Sourcing Services LLCc1a0f3be-d848-4728-a5e8-c14d63ec0af72024-06-21WarningsExact identifier
ndc (product): 70677-1229

Reported adverse events (FAERS/openFDA)#

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