Cystex Max Strength UTI Pain Relief
Cystex Max Strength UTI Pain Relief is an FDA drug label for the active ingredient CYSTEX MAX STRENGTH UTI PAIN RELIEF manufactured by Clarion Brands LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260727.
- Generic name
- CYSTEX MAX STRENGTH UTI PAIN RELIEF
- Manufacturer
- Clarion Brands LLC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69693-519
- Application
- 505G(a)(3)
- Label effective
- 20260727
About this product
Cystex Max Strength UTI Pain Relief is an FDA-registered drug product whose active ingredient is CYSTEX MAX STRENGTH UTI PAIN RELIEF. It is labelled by Clarion Brands LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69693-519, application 505G(a)(3), label effective 20260727. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing CYSTEX MAX STRENGTH UTI PAIN RELIEF are most often described in connection with: fast relief, urinary pain, burning urgency, frequency associated, tract infections, exceed days, without consulting, doctor see. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
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
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
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 Strength UTI Pain Relief used for?
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.
Who makes Cystex Max Strength UTI Pain Relief?
Clarion Brands LLC is the labeler of record for Cystex Max Strength UTI Pain Relief.
What form does Cystex Max Strength UTI Pain Relief come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Cystex Max Strength UTI Pain Relief prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Cystex Max Strength UTI Pain Relief been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.