Uristat Ultra Tablet
FDA Label NDC 63029-105

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Uristat Ultra (NDC 63029-105). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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)

→ Purpose

→ Use

→ Warnings

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

Active Ingredient (In Each Tablet)

Phenazopyridine hydrochloride 99.5 mg

Purpose

Urinary analgesic

Use

fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections

Warnings

Do not exceed recommended dosage

Ask A Doctor Before Use If You Have

kidney disease
allergies to foods, preservatives, or dyes
had a hypersensitive reaction to phenazopyridine

When Using This Product

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.

Stop Use And Ask A Doctor If

your symptoms last for more than 2 days
you suspect you are having an adverse reaction to the medication

If Pregnant Or Breast-Feeding,

ask a health care professional before use.

Keep Out Of Reach Of Children.

In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
Children under 12 years of age: consult a doctor.
Do not use for more than 2 days (12 tablets) without consulting a doctor

Other Information

This product may stain contact lenses
This product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
Long term administration of phenazopyridine HCl 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
Store at 20°-25° C (68°-77° F) in a dry place and protect from light.

Inactive Ingredients

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, silica and starch.