Phenazopyridine is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).

Phenazopyridine is used to treat urinary symptoms such as pain or burning, increased urination, and increased urge to urinate. These symptoms can be caused by infection, injury, surgery, catheter, or other conditions that irritate the bladder.

Phenazopyridine will treat urinary symptoms, but this medication will not treat a urinary tract infection.. Take any antibiotic that your doctor prescribes to treat an infection.

Phenazopyridine may also be used for purposes not listed in this medication guide.

You should not use phenazopyridine if you have kidney disease.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take phenazopyridine after meals.

Drink plenty of liquids while you are taking phenazopyridine.

Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not harmful. Darkened urine may also cause stains to your underwear that may be permanent.

Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.

This medication can cause unusual results with urine tests. Tell any doctor who treats you that you are using phenazopyridine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Dysuria:

190 to 200 mg orally 3 times a day

Comments:
-Take this drug after a meal.
-Take this drug with a full glass of water.
-This drug should not be used longer than 2 days concomitantly with an antibacterial, because of the lack of evidence that the combined administration of this drug and an antibacterial provides greater benefit than the antibacterial alone after 2 days.

Use: For the symptomatic relief of pain, burning, urgency, frequency, and other discomfort arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters

Usual Pediatric Dose for Dysuria:

12 years and older:
190 to 195 mg orally 3 times a day

Comments:
-Take this drug after a meal.
-Take this drug with a full glass of water.
-This drug should not be used longer than 2 days concomitantly with an antibacterial, because of the lack of evidence that the combined administration of this drug and an antibacterial provides greater benefit than the antibacterial alone after 2 days.

Use: For the symptomatic relief of pain, burning, urgency, frequency, and other discomfort arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters

You should not use phenazopyridine if you are allergic to it, or if you have kidney disease.

To make sure phenazopyridine is safe for you, tell your doctor if you have:

• liver disease;

• diabetes; or

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

FDA pregnancy category B. Phenazopyridine is not expected to harm an unborn baby. Do not use phenazopyridine without a doctor's advice if you are pregnant.

It is not known whether phenazopyridine passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not use this medication while wearing soft contact lenses. Phenazopyridine can permanently discolor soft contact lenses.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Phenazopyridine may cause serious side effects. Stop using phenazopyridine and call your doctor at once if you have:

• little or no urinating;

• swelling, rapid weight gain;

• confusion, loss of appetite, pain in your side or lower back;

• fever, pale or yellowed skin, stomach pain, nausea and vomiting; or

• blue or purple appearance of your skin.

Common side effects of phenazopyridine may include:

• headache;

• dizziness; or

• upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with phenazopyridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to phenazopyridine.

Phenazopyridine can interfere with laboratory tests, including urine tests for glucose (sugar) and ketones. If you have diabetes, you should use Clinitest rather than Tes-Tape or Clinistix to test your urine for sugar. Urine tests for ketones (Acetest and Ketostix) may give false results. Before you have any tests, tell the laboratory personnel and doctor that you take this medication.

Phenazopyridine stains clothing and contact lenses. Avoid wearing contact lenses while taking this medicine.

Do not let anyone else take your medication. Your prescription is probably not refillable.

If you still have symptoms after you finish the phenazopyridine, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Azo Gantanol® (containing Phenazopyridine, Sulfamethoxazole)
• Azo Gantrisin® (containing Phenazopyridine, Sulfisoxazole)
• Pyridium Plus® (containing Hyoscyamine, Phenazopyridine, Secbutabarbital)
• Tija® (containing Oxytetracycline, Phenazopyridine, Sulfamethizole)
• Urelief Plus® (containing Hyoscyamine, Phenazopyridine, Secbutabarbital)
• Urobiotic-250® (containing Oxytetracycline, Phenazopyridine, Sulfamethizole)