Drug Facts
d1a800b0-cd33-487a-baf9-bd116abf478d
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Phenazopyridine Hydrochloride 97.5 mg .
Purpose
Urinary Analgesic
Medication Information
Purpose
Urinary Analgesic
Description
Phenazopyridine Hydrochloride 97.5 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
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 Silicate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene glycol,
Polyvinylpyrrolidone, Pregelatinized Starch,
Silicon Dioxide and Sodium Starch Glycolate.
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
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
Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
Active Ingredient (in Each Tablet)
Phenazopyridine Hydrochloride 97.5 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
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 Silicate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene glycol,
Polyvinylpyrrolidone, Pregelatinized Starch,
Silicon Dioxide and Sodium Starch Glycolate.
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
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
Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))
Phenazopyridine Hydrochloride 97.5 mg .
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:03.013652 · Updated: 2026-03-14T22:54:14.381059