TheraCran One is produced from the berry fruit of a North American evergreen shrub. This medicine is acidic and can interfere with unwanted bacteria in the urinary tract. This medicine is also believed to act as a diuretic ("water pill").

TheraCran One (as juice or in capsules) has been used in alternative medicine as a possibly effective aid in preventing symptoms such as pain or burning with urination. This medicine will not treat the bacteria that causes a bladder infection.

Other uses not proven with research have included: urination problems caused by an enlarged prostate; reducing urine odor to improve quality of life in people with urinary incontinence; or healing the skin around the opening of a urostomy (a surgical opening formed to direct urine away from the bladder).

It is not certain whether TheraCran One is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. This medicine should not be used in place of medication prescribed for you by your doctor.

TheraCran One is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

TheraCran One may also be used for purposes not listed in this product guide.

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use TheraCran One, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Drink plenty of liquids while you are taking TheraCran One.

The chewable tablet must be chewed before you swallow it.

Do not use different forms (juice, tablets, capsules, etc) of cranberry at the same time without medical advice. Using different formulations together increases the risk of an overdose.

Call your doctor if the condition you are treating with TheraCran One does not improve, or if it gets worse while using this product.

Store TheraCran One in a sealed container as directed on the product label, away from heat and light.

You should not use this product if you are allergic to TheraCran One.

Ask a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have:

• a history of kidney stones;

• cirrhosis or other liver disease (some TheraCran One products may contain alcohol);

• diabetes (some TheraCran One products may contain high amounts of sugar);

• a stomach disorder; or

• if you are allergic to aspirin.

It is not known whether TheraCran One will harm an unborn baby. Do not use this product without medical advice if you are pregnant.

Cranberry may pass into breast milk and may harm a nursing baby. Do not use this product without medical advice if you are breast-feeding a baby.

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra TheraCran One to make up the missed dose.

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

Avoid drinking more than 1 liter (34 ounces) of cranberry juice daily over a long period of time. You could develop kidney stones with long-term use of cranberry juice in large amounts.

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.

Stop using TheraCran One and call your healthcare provider at once if you have:

• continued pain or burning when you urinate;

• vomiting, severe stomach pain; or

• signs of a kidney stone--painful or difficult urination, pink or red urine, nausea, vomiting, and waves of sharp pain in your side or back spreading to your lower stomach and groin.

Common side effects of TheraCran One may include:

• upset stomach;

• nausea, vomiting; or

• diarrhea.

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.

Do not take TheraCran One without medical advice if you are taking warfarin (Coumadin, Jantoven).

Other drugs may interact with cranberry, 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.