Azuphen MB

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.

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

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

Stop using this medicine and call your doctor at once if you have:

• severe dizziness, blurred vision, fast heart rate;

• painful or difficult urination; or

• shortness of breath.

Older adults may be more likely to have side effects from this medication.

Methylene blue will most likely cause your urine or stools to appear blue or green in color. This is a normal side effect of the medication and will not cause any harm.

Common side effects may include:

• dizziness, drowsiness;

• dry mouth; or

• nausea, vomiting.

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.

• 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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Azuphen MB or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Azuphen MB. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately.

Patients should be advised that urine will be colored blue when taking this medication. Do not exceed recommended dosage.

Cardiovascular - rapid pulse, flushing
Central Nervous System - blurred vision, dizziness, drowsiness
Respiratory - shortness of breath or troubled breathing
Genitourinary - difficult micturition, acute urinary retention
Gastrointestinal - dry mouth, nausea and vomiting

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Burel Pharmaceuticals, Inc at 1-601-706-9819 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

Store in a cool, dry place at controlled room temperature 15° to 30°C (59° to 86°F). Keep container tightly closed. Protect from moisture and direct sunlight.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

KEEP OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Note: Patients should be advised that urine will be colored blue when taking this medication.

Rx Only

Manufactured for:
Burel Pharmaceuticals, Inc
Richland, MS 39218

Rev. 7/2015

NDC 35573-314-10

Azuphen MB®

URINARY ANTISEPTIC

Each Capsule Contains:

Rx ONLY

Buruel Pharmaceuticals

100 Capsules

Azuphen MB™ is a trademark of Burel Pharmaceuticals, Inc
Manufactured for:
Burel Pharmaceuticals, Inc
Richland, MS 39218

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.

Some side effects of Azuphen MB may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.