Nuvicare-Urinary Pain Relief Maximum Strength

PHENAZOPYRIDINE HYDROCHLORIDE ORAL HUMAN OTC DRUG

Nuvicare-Urinary Pain Relief Maximum Strength is an FDA drug label for the active ingredient PHENAZOPYRIDINE HYDROCHLORIDE manufactured by NUVICARE 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 20260803.

Generic name
PHENAZOPYRIDINE HYDROCHLORIDE
Manufacturer
NUVICARE LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
84324-042
Application
N/A
Label effective
20260803

About this product

Nuvicare-Urinary Pain Relief Maximum Strength is an FDA-registered drug product whose active ingredient is PHENAZOPYRIDINE HYDROCHLORIDE. It is labelled by NUVICARE LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 84324-042, label effective 20260803. It is one of 20 FDA drug label records sharing the active ingredient PHENAZOPYRIDINE HYDROCHLORIDE. 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 PHENAZOPYRIDINE HYDROCHLORIDE are most often described in connection with: urinary pain, burning urgency, frequency associated, tract infections. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each tablet) Phenazopyridine Hydrochloride 99.5 mg

Indications & Usage

Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

Dosage & Administration

Directions ■ Adults and children 12 years and older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor. ■ Children under 12: Do not use without consulting a doctor.

Warnings

Warnings Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

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How products containing PHENAZOPYRIDINE HYDROCHLORIDE compare

FDA lists 20 drug label records with PHENAZOPYRIDINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — REMEDYREPACK INC. 3
— — NuCare Pharmaceuticals, Inc. 2
— — Rising Pharma Holdings, Inc. 2
— — Cardinal Health 1
— — GPT Pharmaceuticals Private Limited 1

Frequently asked questions

What is Nuvicare-Urinary Pain Relief Maximum Strength used for?
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

Who makes Nuvicare-Urinary Pain Relief Maximum Strength?
NUVICARE LLC is the labeler of record for Nuvicare-Urinary Pain Relief Maximum Strength. 20 FDA label records share the active ingredient PHENAZOPYRIDINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Nuvicare-Urinary Pain Relief Maximum Strength 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 Nuvicare-Urinary Pain Relief Maximum Strength 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.

Are there other products containing PHENAZOPYRIDINE HYDROCHLORIDE?
Yes. 20 FDA drug label records list PHENAZOPYRIDINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Nuvicare-Urinary Pain Relief Maximum Strength 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.