Urogesic Blue

• Edwards Pharmaceuticals, Inc.

Inactive ingredients include: microcrystalline cellulose, NF, mannitol, USP, croscarmellose sodium, NF, magnesium stearate, NF and lake blend blue.

HYOSCYAMINE SULFATE is an alkaloid of belladonna. Exists as a white crystalline powder. Affected by light. It is very soluble in water; freely soluble in alcohol; practically insoluble in ether.

METHENAMINE exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water; soluble in alcohol and in chloroform.

METHYLENE BLUE exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

MONOBASIC SODIUM PHOSPHATE exists as a white crystalline powder. Its solutions are acidic to litmus. It is freely soluble in water and practically insoluble in alcohol.

Adults

One tablet orally 4 times per day followed by liberal fluid intake.

Older Children

Dosage must be individualized by physician. Not recommended for use in children up to 6 years of age.

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

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; or

• if you are allergic to belladonna (Donnatal and others).

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.

This medicine should not be given to a child younger than 7 years old.

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

Avoid taking an antacid or anti-diarrhea medicine within 1 hour before or after you take hyoscyamine, methenamine, methylene blue, and sodium biphosphate. Antacids or anti-diarrhea medicine can make it harder for your body to absorb hyoscyamine.

If you also take ketoconazole (Nizoral), wait at least 2 hours after taking it before you take hyoscyamine, methenamine, methylene blue, and sodium biphosphate.

Many drugs can interact with this medicine. Not all possible interactions are listed here. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all your medications and any you start or stop using, especially:

• neostigmine or pyridostigmine;

• bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;

• bronchodilators such as ipratropium or tiotropium;

• cold or allergy medicine that contains an antihistamine;

• a diuretic or "water pill";

• an MAO inhibitor--furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine;

• medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;

• medication to treat gout, kidney stones, or an electrolyte imbalance (such as low levels of potassium);

• medication to treat symptoms of Alzheimer's disease or Parkinson's disease;

• narcotic pain or cough medication--codeine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, propoxyphene, and others; or

• sulfa drugs.

This list is not complete and many other drugs can interact with hyoscyamine, methenamine, methylene blue, and sodium biphosphate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• 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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A fast heartbeat.
• Blurred eyesight.
• Dizziness.
• Feeling very sleepy.
• Feeling confused.