Drugplain

Cystex Max UTI Pain Relief 99.5 mg/1

Phenazopyridine hydrochloride · TABLET · Clarion Brands, LLC

No Recall History
Plain English

Cystex Max UTI Pain Relief is a tablet containing phenazopyridine hydrochloride at 99.5 mg/1, taken oral. Manufactured by Clarion Brands, LLC.

Key Facts

Brand Name
Cystex Max UTI Pain Relief
Generic Name
Phenazopyridine hydrochloride
NDC Code (Product)
69693-514
Manufacturer
Clarion Brands, LLC
Strength
99.5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
08/02/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

sulphaemoglobinaemia27 reports
pain25 reports
nausea22 reports
myocardial infarction17 reports
urinary tract infection17 reports
fatigue16 reports
headache16 reports
dyspnoea15 reports
hypertension15 reports
vomiting15 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.

Dosage & Administration

Directions 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

Warnings

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.

Frequently Asked Questions

What is Cystex Max UTI Pain Relief used for?

Cystex Max UTI Pain Relief contains Phenazopyridine hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Cystex Max UTI Pain Relief a controlled substance?

Cystex Max UTI Pain Relief is not classified as a controlled substance by the DEA.

What is the generic name for Cystex Max UTI Pain Relief?

The generic name for Cystex Max UTI Pain Relief is Phenazopyridine hydrochloride. There are 12 other brand versions of Phenazopyridine hydrochloride.

What is the NDC code for Cystex Max UTI Pain Relief 99.5 mg/1?

The NDC (National Drug Code) for Cystex Max UTI Pain Relief 99.5 mg/1 is 69693-514, listed by Clarion Brands, LLC.