Cystex Max UTI Pain Relief

Manufacturer
Clarion Brands, LLC
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:55

Label at a glance#

ProductCystex Max UTI Pain Relief
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure14 sections

Dosage and administration

Adults and children 12 years of age and older: take 2 tablets 3 times a day with a full glass of water or after meals as needed children under 12 years: ask a doctor

Storage and handling

WARNING: 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°F-86°F (15°C-30°C) in a dry place and protect from light Tamper evident: Product i...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine hydrochloride 99.5 mg

Purpose

OTC - PURPOSE SECTION

Urinary tract analgesic

INDICATIONS & USAGE SECTION

Use fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days without consulting a doctor; see Directions.

Warnings

WARNINGS SECTION

  • Do not exceed recommended dosage
  • 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.

Do not use

OTC - DO NOT USE SECTION

if you have Glucose-6-Phosphare Dehydrogenase (G6PD) deficiency unless approved by your doctor

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

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • 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.
  • do not use for more than 2 days (12 tablets) without consulting a doctor

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use
Keep out of the reach of children.  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 older:take 2 tablets 3 times a day with a full glass of water or after meals as needed

  • children under 12 years:
  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • WARNING: 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°F-86°F (15°C-30°C) 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc, triacetin

Questions

OTC - QUESTIONS SECTION

call 1-844-297-8394

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STRENGTH

Cystex®
Urinary Health

Phenazopyridine Hydrochloride 99.5 mg

MAX UTI PAIN RELIEF

FAST-ACTING UTI PAIN RELIEF

Strongest UTI Pain Relief Available
for Fast-Acting Relief of Pain & Burning *

√Relief of Pain, Burning, & Urgency

√  Targets Painat the Source of the UTI

STARTS
WORKING

IN AS LITTLE AS 
15 MINUTES

Cystex is not intended to replace a doctor's care.

24 Tablets

TAMPER EVIDENT: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED.

1000284

REV XX/XX REESECODE

For more information on
Cystex Max Strength UTI Pain
Relief or other products, please
visit www.cystex.comor call
844-297-8394

Distributed by: Cystex LLC
811 Broad Street, Suite 600
Chattanooga, TN 37402  ©2024
*without a prescription

Carton
Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN4
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD4
1094147phenazopyridine HCl 99.5 MG Oral TabletSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.cystex.com/cystex-max-strength-uti-pain-reliefcarton.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-514-24Cystex Max UTI Pain Relief24 in 1 BLISTER PACKTABLET244
69693-514-24Cystex Max UTI Pain Relief1 in 1 CARTONTABLET14

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
69693-51469693-514-24

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-26monthly-update2026-06-03 17:46:39

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
Cystex Max UTI Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEClarion Brands, LLCa4d34c20-62af-4a3c-ad2c-046ba08d1ef62026-01-14WarningsExact identifier
ndc (package): 69693-514-24
ndc (product): 69693-514
ndc11 (package): 69693051424
spl id: 485b5018-57f0-90d7-e063-6294a90ae5e2
spl set id: a4d34c20-62af-4a3c-ad2c-046ba08d1ef6

Reported adverse events (FAERS/openFDA)#

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