Nuvicare-urinary Pain Relief Maximum Strength Tablet
FDA Label NDC 84324-042

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Nuvicare-urinary Pain Relief Maximum Strength (NDC 84324-042). 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 active ingredient (in each tablet), purpose, use, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Phenazopyridine Hydrochloride 99.5 mg

Purpose

Urinary tract analgesic

Use

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

Warnings

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

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.

Other 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°-86°F) in a dry place and protect from light

Inactive Ingredients

carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.

* Please review the disclaimer below.