URO-PAIN Maximum Strength
URO-PAIN Maximum Strength is an FDA drug label for the active ingredient PHENAZOPYRIDINE HYDROCHLORIDE manufactured by Rising Pharma Holdings, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231214.
- Generic name
- PHENAZOPYRIDINE HYDROCHLORIDE
- Manufacturer
- Rising Pharma Holdings, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 57237-330
- Application
- N/A
- Label effective
- 20231214
Active ingredients
Indications & Usage
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Dosage & 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.
Contraindications
Not available.
Warnings
Warnings Ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to Phenazopyridine Hydrochloride Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician. 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. 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. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
Adverse Reactions
Not available.