Cystex Max Strength UTI Pain Relief - Clarion Brands LLC

Manufacturer
Clarion Brands LLC
Effective date
2026-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-29 05:10:16

Label at a glance#

ProductCystex Max Strength UTI Pain Relief
Active ingredientPHENAZOPYRIDINE HYDROCHLORIDE
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Phenazopyridine hydrochloride 99.5 mg

OTC - PURPOSE SECTION

Urinary tract analgesic

OTC - DO NOT USE SECTION

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

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

OTC - STOP USE SECTION

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

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 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.

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.

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 SAFETY INFORMATION

  • 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 INGREDIENT SECTION

carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch

May contain: corn starch

OTC - QUESTIONS SECTION

call 1-844-297-8394

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cystex®

15 MINUTE RELIEF


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 *

√Maximum relief of Pain, Burning, & Urgency

√ Targets Pain at the Source

STARTS
WORKING
IN AS LITTLE AS
15 MINUTES

24 Tablets

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

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

1000452

For more information on
Cystex Max Strength UTI Pain
Relief or other products, please
visit www.cystex.com

Distributed by: Cystex LLC
1208 King Street, Suite 605

Chattanooga, TN 37403 ©2026
*without a prescription

CartonCarton

Blister LabelBlister Label

Product Linked Resources#

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

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69693-51969693-519-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
Cystex Max Strength UTI Pain ReliefCYSTEX MAX STRENGTH UTI PAIN RELIEFClarion Brands LLC57482f71-80d3-b20d-e063-6394a90a0cf42026-07-27WarningsExact identifier
ndc (package): 69693-519-24
ndc (product): 69693-519
ndc11 (package): 69693051924
spl id: 57482f71-80d4-b20d-e063-6394a90a0cf4
spl set id: 57482f71-80d3-b20d-e063-6394a90a0cf4

Reported adverse events (FAERS/openFDA)#

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