uro-paintm
f0817ef7-c269-4881-81d9-ffc64b404b7e
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
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride
Active Ingredient
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
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 and 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 42229-5
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg License Code:
RA/Drug/RAJ.-1750
Issued: 09/2023
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 if
- 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
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Section 51727-6
Inactive ingredients carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.
Section 53414-9
If pregnant or breastfeeding, ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use.
Section 55105-1
Purpose
Urinary tract analgesic
Section 60561-8
Other Information
- This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer
- 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 (59o-86oF) in a dry place and protect from light.
Tamper evident: Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.
Packaging
NDC 57237-331-03
URO-PAINTM
Phenazopyridine Hydrochloride Tablets, 95 mg
Urinary Tract Pain Relief
- Relieves Pain, Burning and Urgency
- Targets the source of Pain
Structured Label Content
Warnings and Precautions (34071-1)
Warnings
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride
Active Ingredient (55106-9)
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
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 and 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.
Section 42229-5 (42229-5)
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg License Code:
RA/Drug/RAJ.-1750
Issued: 09/2023
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 if
- 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)
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Section 51727-6 (51727-6)
Inactive ingredients carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.
Section 53414-9 (53414-9)
If pregnant or breastfeeding, ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use.
Section 55105-1 (55105-1)
Purpose
Urinary tract analgesic
Section 60561-8 (60561-8)
Other Information
- This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer
- 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 (59o-86oF) in a dry place and protect from light.
Tamper evident: Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.
Packaging
NDC 57237-331-03
URO-PAINTM
Phenazopyridine Hydrochloride Tablets, 95 mg
Urinary Tract Pain Relief
- Relieves Pain, Burning and Urgency
- Targets the source of Pain
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:41.570839 · Updated: 2026-03-14T23:02:23.126471