FDA.reportPublic FDA data

Phenazopyridine Hydrochloride - GPT Pharmaceuticals Private Limited

Manufacturer
GPT Pharmaceuticals Private Limited
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:12

Label at a glance#

ProductPhenazopyridine Hydrochloride
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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 in a tightly closed container

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine Hydrochloride 99.5 mg

Purpose

OTC - PURPOSE SECTION

Urinary tract analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to Phenazopyridine Hydrochloride

Do not use

OTC - DO NOT USE SECTION

if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician

When using this product

OTC - WHEN USING SECTION

  • 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 breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

Keep out of 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 call (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 information

STORAGE AND HANDLING SECTION

  • 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 in a tightly closed container

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicone dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, maize (corn) starch, microcrystalline cellulose, povidone, pregelatinized starch

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN1
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD1
1094147phenazopyridine HCl 99.5 MG Oral TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50696-003-01Phenazopyridine Hydrochloride25000 in 1 DRUMTABLET250001

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50696-00350696-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
STARCH, CORNO8232NY3SJIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
PHENAZOPYRIDINE HYDROCHLORIDE0EWG668W17ACTIB

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
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEGPT Pharmaceuticals Private Limited7332cbf1-ceda-415b-b4d5-a100057a7d012026-05-12WarningsExact identifier
ndc (package): 50696-003-01
ndc (product): 50696-003
ndc11 (package): 50696000301
spl id: 51a1c6ea-0152-879a-e063-6394a90af1df
spl set id: 7332cbf1-ceda-415b-b4d5-a100057a7d01

Reported adverse events (FAERS/openFDA)#

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