Ustell

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Methenamine and methylene blue work as mild antiseptics that fight bacteria in the urine and bladder.

Phenyl salicylate is a mild pain reliever.

Sodium biphosphate is a form of phosphorus, which is a naturally occurring substance that is important in every cell in the body.

Hyoscyamine, methenamine, methylene blue, phenyl salicylate, sodium biphosphate is a combination medicine used to treat bladder irritation (pain, spasms, inflammation) caused by urinary tract infection. This medicine is also used to prevent bladder discomfort during a medical procedure.

Hyoscyamine, methenamine, methylene blue, phenyl salicylate, sodium biphosphate may also be used for purposes not listed in this medication guide.

Many drugs can interact with methylene blue. During your treatment with this medicine, do not start or stop using any other medications without your doctor's advice.

If you take an antidepressant or psychiatric medication, call your doctor right away if you have signs of a serious drug interaction, including: confusion, memory problems, feeling hyperactive (mentally or physically), loss of coordination, muscle twitching, shivering, sweating, diarrhea, and/or fever.

You should not use this medicine if you are allergic to hyoscyamine, methenamine, methylene blue, phenyl salicylate, or sodium biphosphate.

During your treatment with this medicine, do not start or stop using any other medications unless your doctor tells you to.

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

• heart disease;
• a heart rhythm disorder;
• congestive heart failure;
• coronary heart disease;
• a heart valve disorder;
• glaucoma;
• an enlarged prostate or bladder obstruction;
• myasthenia gravis;
• an ulcer or obstruction in your stomach;
• an allergy to belladonna (Donnatal and others); or
• an allergy to salicylates (such as aspirin, choline magnesium trisalicylate, magnesium salicylate).

It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Drink plenty of liquids while you are taking this medicine.

Hyoscyamine can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

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

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.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Drink plenty of liquids while you are taking this medicine.

Hyoscyamine can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your or your child's symptoms do not improve or if they get worse, call your doctor.

Stop using this medicine and check with your doctor right away if you or your child have blurred vision, dizziness, or rapid pulse.

This medicine will make your urine to be colored blue. This is normal and is nothing to worry about.

This medicine will not cure a serious urinary tract infection and will only work to relieve symptoms as long as you continue to take it.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• dizziness
• rapid pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blue-colored urine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Ustell for longer than you were told by your doctor.
• This medicine may prevent other drugs taken by mouth from getting into the body. If you take other drugs by mouth, you may need to take them at some other time than this medicine. Talk with your doctor.
• Use with care in children. Talk with the doctor.
• If Ustell is taken by accident, get medical help right away.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Ustell while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Feeling sleepy.
• Dry mouth.
• Flushing.
• Change in color of urine or stool to blue or green.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

NDC 0076-0903-01

Rx Only

Ustell™

100 Capsules

Ustell™ is a trademark of Stellar Pharmacal

Distributed by:

BIOCOMP PHARMA, INC.

San Antonio, Texas 78230

Manufactured for:

STELLAR PHARMACAL

Ft. Lauderdale, FL 33306