Azo Urinary Pain Relief
3d0298b7-eaec-488b-9cab-19af4614ff53
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each tablet) Phenazopyridine Hydrochloride 95 mg
Medication Information
Warnings and Precautions
Warnings Please read insert for important precautions.
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride.
Indications and Usage
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Dosage and Administration
Directions
- Adults and children 12 years or older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor.
- Children under 12: Do not use without consulting a doctor.
Description
Active ingredient (in each tablet) Phenazopyridine Hydrochloride 95 mg
Section 34072-9
Other Inf ormation
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
- This product may stain soft contact lenses and other items if handled after touching tablets
- Store at room temperature (59-86 F) in a dry place and protect from light
- Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.
Section 50565-1
Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and ask doctor
- your symptoms last for more than 2 days
- you suspect you are having an adverse reaction to the medication.
Section 50567-7
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.
Section 50570-1
Caution:Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Section 51727-6
Inactive ingredients microcrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate. May also contain corn starch.
Section 51945-4
AZO
Urinary Pain Relief
- Relieves pain, burning & urgency
- Targets the source of pain
#1 Most Trusted Brand
Tablets
95 mg Phenazopyridine Hydrochloride
Section 53413-1
Distributed by i-Health, Inc.
25 Bacon Road, Enfield, CT 06082
Made in India.
Most Trusted Brand based on Nielsen data through 3/23/2013.
For questions, concerns, or to report an adverse event, call (800) 722-3476
www.azoproducts.com
Section 55105-1
Purpose
Urinary analgesic
Drug Facts
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
Structured Label Content
Indications and Usage (34067-9)
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Dosage and Administration (34068-7)
Directions
- Adults and children 12 years or older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor.
- Children under 12: Do not use without consulting a doctor.
Warnings and Precautions (34071-1)
Warnings Please read insert for important precautions.
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride.
Section 34072-9 (34072-9)
Other Inf ormation
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
- This product may stain soft contact lenses and other items if handled after touching tablets
- Store at room temperature (59-86 F) in a dry place and protect from light
- Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.
Section 50565-1 (50565-1)
Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
Stop use and ask doctor
- your symptoms last for more than 2 days
- you suspect you are having an adverse reaction to the medication.
Section 50567-7 (50567-7)
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.
Section 50570-1 (50570-1)
Caution:Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Section 51727-6 (51727-6)
Inactive ingredients microcrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate. May also contain corn starch.
Section 51945-4 (51945-4)
AZO
Urinary Pain Relief
- Relieves pain, burning & urgency
- Targets the source of pain
#1 Most Trusted Brand
Tablets
95 mg Phenazopyridine Hydrochloride
Section 53413-1 (53413-1)
Distributed by i-Health, Inc.
25 Bacon Road, Enfield, CT 06082
Made in India.
Most Trusted Brand based on Nielsen data through 3/23/2013.
For questions, concerns, or to report an adverse event, call (800) 722-3476
www.azoproducts.com
Section 55105-1 (55105-1)
Purpose
Urinary analgesic
Drug Facts
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:05.858552 · Updated: 2026-03-14T23:12:14.139281