Drug Facts
97ea2a3e-c1a0-437d-ac2a-2128e193183b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Phenazopyridine Hydrochloride 99.5 mg .
Purpose
Urinary Analgesic
Medication Information
Purpose
Urinary Analgesic
Description
Phenazopyridine Hydrochloride 99.5 mg .
Use
Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract
infections.
Section 51945-4
Warnings
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
Inactive Ingredients
corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and triacetin
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 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.
Keep Out of Reach of Children
In case of an overdose, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast Feeding,
Ask a health professional before use.
Ask Doctor Before Use If You Have
■ kidney disease
■ allergies to food, preservatives or dyes
■ had a hypersensitive reaction to phenazopyridine
Active Ingredient (in Each Tablet)
Phenazopyridine Hydrochloride 99.5 mg .
Structured Label Content
Use
Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract
infections.
Section 51945-4 (51945-4)
Purpose
Urinary Analgesic
Warnings
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
Inactive Ingredients (Inactive ingredients)
corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, 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 Doctor If (Stop use and ask 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.
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 right away.
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 food, preservatives or dyes
■ had a hypersensitive reaction to phenazopyridine
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))
Phenazopyridine Hydrochloride 99.5 mg .
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:11.082821 · Updated: 2026-03-14T23:03:07.791514