Active Ingredient
(in each tablet)
Phenazopyridine hydrochloride 95mg
Uristatuti Relief Pak
FDA Label NDC 0440-8065
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Liberty Pharmaceuticals, Inc. for the product Uristatuti Relief Pak (NDC 0440-8065). 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, 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
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
corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, and talc
Questions?
Call 1-800-344-7239 or visit our website at www.Uristat.com
©2015 Distributed by:
Insight Pharmaceuticals LLC
Tarrytown, NY 10591
A Prestige Brands Company
Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92882
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Phenazopyridine Hydrochloride 95mg
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