FDA.reportPublic FDA data

PHENAZOPYRIDINE HYDROCHLORIDE TABLETS

Manufacturer
Drug Ocean LLC
Effective date
2024-03-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:18

Label at a glance#

ProductPHENAZOPYRIDINE HYDROCHLORIDE
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

OTC - PURPOSE SECTION

Purpose

Urinary tract analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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

Do not useif 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 if

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding,ask a healthcare professional before use. A pregnancy test and consultation with a healthcare 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.

INACTIVE INGREDIENT SECTION

Inactive ingredients  carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.

OTHER SAFETY INFORMATION

Other Information

  • This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer
  • 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 o-86 oF) in a dry place and protect from light.

Tamper evident:Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.

SPL UNCLASSIFIED SECTION

Questions or comments? Call 1-844-200-6566

Distributed by:
Drug Ocean LLC
1 Bridge Plaza, North Central Road,
6th Floor, Suite 675, 
Fort Lee, NJ 07024

Made in India

Mfg License Code:
RA/Drug/RAJ.-1750

ORG 03/2024

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Ocean NDC 70985- 028-14

Phenazopyridine Hydrochloride Tablets, 95 mg

Urinary Tract Pain Relief

  • Relieves Pain, Burning and Urgency
  • Targets the source of Pain

30 Tablets

Phenazopyridine HCl Tablets- CartonPhenazopyridine HCl Tablets- Carton

Blister Label

Phenazopyridine HCl Tablets- BlisterPhenazopyridine HCl Tablets- Blister

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094126phenazopyridine HCl 95 MG Oral TabletPSN2
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCD2
1094126phenazopyridine HCl 95 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70985-028-142026-01-29C16284748780-149896155-abe8-586f-e063-e6dba90add90PHENAZOPYRIDINE HYDROCHLORIDE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70985-028-14PHENAZOPYRIDINE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET302
70985-028-14PHENAZOPYRIDINE HYDROCHLORIDE1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70985-028PHENAZOPYRIDINE HYDROCHLORIDE TABLET [DRUG OCEAN LLC]22 package rows20240328_5539356d-10ed-44df-8d17-1af6bd6d982f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70985-02870985-028-14

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
NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CARNAUBA WAXR12CBM0EIZIACT
MAGNESIUM STEARATE70097M6I30IACT
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
14a55430-a266-a98b-e063-6394a90a34635539356d-10ed-44df-8d17-1af6bd6d982f2024-03-27WarningsExact identifier
spl id: 14a55430-a266-a98b-e063-6394a90a3463
spl set id: 5539356d-10ed-44df-8d17-1af6bd6d982f

Reported adverse events (FAERS/openFDA)#

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