Otc - Active Ingredient
Phenazopyridine hydrochloride 99.5 mg
Cystex Max Strength Uti Pain Relief Tablet
FDA Label NDC 69693-519
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clarion Brands Llc for the product Cystex Max Strength Uti Pain Relief (NDC 69693-519). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - do not use, otc - when using, otc - stop use, indications & usage, warnings, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Urinary tract analgesic
Otc - Do Not Use
if you have Glucose-6-Phosphare Dehydrogenase (G6PD) deficiency unless approved by your doctor
Otc - When Using
- 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
- your symptoms last for more than 2 days
- you suspect you are having an adverse reaction to the medication
Indications & Usage
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
- 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
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
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
carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch
May contain: corn starch
Otc - Questions
call 1-844-297-8394
Otc - Keep Out Of Reach Of Children
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
* Please review the disclaimer below.
