Drugplain

URO-PAIN Maximum Strength 99.5 mg/1

Phenazopyridine Hydrochloride · TABLET · Rising Pharma Holdings, Inc.

No Recall History
Plain English

URO-PAIN Maximum Strength is a prescription tablet containing phenazopyridine hydrochloride at 99.5 mg/1, taken oral. Manufactured by Rising Pharma Holdings, Inc..

Key Facts

Brand Name
URO-PAIN Maximum Strength
Generic Name
Phenazopyridine Hydrochloride
NDC Code (Product)
57237-330
Manufacturer
Rising Pharma Holdings, Inc.
Strength
99.5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Marketing Start
12/06/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

sulphaemoglobinaemia27 reports
pain25 reports
nausea22 reports
myocardial infarction17 reports
urinary tract infection17 reports
fatigue16 reports
headache16 reports
dyspnoea15 reports
hypertension15 reports
vomiting15 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.

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.

Frequently Asked Questions

What is URO-PAIN Maximum Strength used for?

URO-PAIN Maximum Strength contains Phenazopyridine Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is URO-PAIN Maximum Strength a controlled substance?

URO-PAIN Maximum Strength is not classified as a controlled substance by the DEA.

What is the generic name for URO-PAIN Maximum Strength?

The generic name for URO-PAIN Maximum Strength is Phenazopyridine Hydrochloride. There are 12 other brand versions of Phenazopyridine Hydrochloride.

What is the NDC code for URO-PAIN Maximum Strength 99.5 mg/1?

The NDC (National Drug Code) for URO-PAIN Maximum Strength 99.5 mg/1 is 57237-330, listed by Rising Pharma Holdings, Inc..