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#
Contacts and useful links#
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
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code | Cystex Max Carton.jpg |
Products#
Every source-derived product name is available through these pages.
- Cystex Max Strength UTI Pain Relief
- PHENAZOPYRIDINE HYDROCHLORIDE
- PHENAZOPYRIDINE
- CARNAUBA WAX
- CROSCARMELLOSE SODIUM
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- STARCH, PREGELATINIZED CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69693-519 | 69693-519-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cystex Max Strength UTI Pain Relief | CYSTEX MAX STRENGTH UTI PAIN RELIEF | Clarion Brands LLC | 57482f71-80d3-b20d-e063-6394a90a0cf4 | 2026-07-27 | Warnings | 69693-519-24 69693-519 69693051924 57482f71-80d4-b20d-e063-6394a90a0cf4 57482f71-80d3-b20d-e063-6394a90a0cf4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

