Drug Facts
7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc6
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Phenazopyridine Hydrochloride 95 mg
Purpose
Urinary Analgesic
Medication Information
Purpose
Urinary Analgesic
Description
Phenazopyridine Hydrochloride 95 mg
Uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Section 51945-4
Warning
Do not exceed recommended dosage
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
Directions
■ Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12 years: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Active Ingredient
Phenazopyridine Hydrochloride 95 mg
Other Information
■ this product may stain contact lenses
■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light
Inactive Ingredients
lactose, corn starch, croscarmellose sodium, microcrystalline
cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate,
pregelatinized starch, silicon dioxide, talc, and triacetin.
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
■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication
Long-term administration of phenazopyridine hydrochloride 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.
If Pregnant Or Breast Feeding
ask a health professional before use.
Ask Doctor Before Use If You Have
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine
Keep Out of the Reach of Children
in case of an overdose,get medical help or contact a Poison Control Center right away 1-800-222-1222.
Structured Label Content
Uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Section 51945-4 (51945-4)
Purpose
Urinary Analgesic
Warning
Do not exceed recommended dosage
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
Directions
■ Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12 years: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Active Ingredient
Phenazopyridine Hydrochloride 95 mg
Other Information
■ this product may stain contact lenses
■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light
Inactive Ingredients
lactose, corn starch, croscarmellose sodium, microcrystalline
cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate,
pregelatinized starch, silicon dioxide, talc, and triacetin.
When Using This Product (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
Long-term administration of phenazopyridine hydrochloride 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.
If Pregnant Or Breast Feeding (If pregnant or breast feeding)
ask a health professional before use.
Ask Doctor Before Use If You Have (Ask Doctor before use if you have)
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine
Keep Out of the Reach of Children (Keep out of the reach of children)
in case of an overdose,get medical help or contact a Poison Control Center right away 1-800-222-1222.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:54.374365 · Updated: 2026-03-14T23:06:01.213422