drug facts
9281da67-6e41-43e3-b8af-290657aa80db
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Urinary Analgesic
Description
Phenazopyridine Hydrochloride 95 mg
Medication Information
Uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Purpose
Urinary Analgesic
Directions
■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Inactive Ingredients
lactose, magnesium silicate, magnesium stearate, microcrystalline
cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch,
croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide.
Description
Phenazopyridine Hydrochloride 95 mg
Warning
Do not exceed recommended dosage
Active Ingredient
Phenazopyridine Hydrochloride 95 mg
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
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.
Package/label Principal Display Panel
Structured Label Content
Uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Purpose
Urinary Analgesic
Directions
■ Adults and children 12 and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
■ Children under 12: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Inactive Ingredients
lactose, magnesium silicate, magnesium stearate, microcrystalline
cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch,
croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide.
Warning
Do not exceed recommended dosage
Active Ingredient
Phenazopyridine Hydrochloride 95 mg
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
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.
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:00:20.186057 · Updated: 2026-03-14T23:00:42.428927