Uristat
f6e24576-e90c-451e-b2f8-261b61a00fcc
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Urinary analgesic
Medication Information
Purpose
Urinary analgesic
Description
Drug Facts
Use
fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections
Section 42229-5
Drug Facts
Warnings
Do not exceed recommended dosage
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
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
Active Ingredient
(in each tablet )
Phenazopyridine hydrochloride 95mg
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 20º-25º C (68º-77º 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
Ask A Doctor Before Use
- Kidney disease
- Allergies to foods, preservatives, or dyes
- Had a hypersensitive reaction to phenazopyridine
Principal Display Panel
Phenazopyridine Hydrochloride 95mg
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.
Structured Label Content
Use
fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections
Section 42229-5 (42229-5)
Drug Facts
Purpose
Urinary analgesic
Warnings
Do not exceed recommended dosage
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
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
Active Ingredient (Active ingredient)
(in each tablet )
Phenazopyridine hydrochloride 95mg
Other Information (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 20º-25º C (68º-77º F) in a dry place and protect from light.
Inactive Ingredients (Inactive ingredients)
corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, and talc
Ask A Doctor Before Use (Ask a doctor before use)
- Kidney disease
- Allergies to foods, preservatives, or dyes
- Had a hypersensitive reaction to phenazopyridine
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Phenazopyridine Hydrochloride 95mg
When Using This Product (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 (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, (If pregnant or breast-feeding,)
ask a health care professional before use.
Keep Out of Reach of Children. (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.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:12.115116 · Updated: 2026-03-14T22:54:30.332332