This medication is used to relieve symptoms caused by irritation of the urinary tract such as pain, burning, and the feeling of needing to urinate urgently or often. This drug does not treat the cause of the urinary irritation, but it can help relieve the symptoms while other treatments take effect. Phenazopyridine is a dye that works as a painkiller to soothe the lining of the urinary tract.

Take this medication by mouth after meals, usually 3 times daily or as directed by your doctor. If you are taking this medication along with antibiotics for symptoms related to a urinary tract infection, or are self-treating, do not take it for more than 2 days without talking to your doctor.

The dosage is based on your medical condition and response to treatment.

Tell your doctor if your condition lasts or gets worse.

Headache, dizziness, or stomach upset may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• yellowing skin/eyes
• dark urine
• signs of kidney problems (such as change in the amount of urine, bloody urine)
• stomach/abdominal pain
• vomiting
• fever
• chills
• easy bruising/bleeding
• unusual tiredness
• shortness of breath
• fast heartbeat
• seizures

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking phenazopyridine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver disease
• blood disorders (such as G6PD deficiency, hemolytic anemia)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Phenazopyridine can dye your urine and tears orange-red. This may stain clothing and contact lenses. Do not wear contact lenses while using this medication. Urine and tears will return to normal color after the medication is stopped.

Tell your doctor if you are pregnant before using this medication.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as urine tests for kidney function, bilirubin, and sugar levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include unusual tiredness, skin color changes, change in the amount of urine, shortness of breath, fast heartbeat, yellowing skin/eyes, easy bleeding/bruising, or seizures.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not take it later for another pain-related condition of the urinary tract unless told to do so by your doctor. A different medication may be necessary in those cases.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.