Kava has been used for anxiety and stress. The US Food and Drug Administration (FDA) has issued a public safety alert about kava and liver problems.

Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details regarding the particular brand you use.

The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

Take this product by mouth as directed. Follow all directions on the product package. If you have any questions, ask your doctor or pharmacist.

This herbal product should not be used for more than 3 months at a time.

If your condition lasts or gets worse, or if you think you may have a serious medical problem, get medical help right away.

See also Warning section.

Nausea, dizziness, drowsiness, headache, mouth numbness, or blurred vision may occur. If any of these effects last or get worse, tell your doctor right away.

Tell your doctor right away if you have any serious side effects, including:

• muscle spasm/stiffness/weakness
• uncontrolled movements (especially of lips and tongue)
• loss of coordination
• shakiness (tremor)
• easy bleeding/bruising
• weight loss
• red/pink urine

Taking kava continuously for a long time may cause reddened eyes, dry/scaly skin, or yellowing hair/skin/nails. These symptoms usually disappear when kava is stopped. Stop taking kava right away if you develop any of these symptoms. Yellowing skin may also be a sign of liver problems. Get medical help right away if you develop yellowing eyes/skin.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking kava, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product:

• depression
• past/current liver disease
• Parkinson's disease

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Alcohol may also increase the risk of serious liver problems. Talk to your doctor if you are using marijuana (cannabis).

Liquid forms of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using kava. Kava may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this product passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some drugs that may interact with this product include:

• drugs that can harm the liver (including acetaminophen, amiodarone, isoniazid, methotrexate, methyldopa, "statins" such as atorvastatin and lovastatin)
• "blood thinners" (such as warfarin)

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe drowsiness, inability to move.

Tell your doctor that you are taking kava. Lab and/or medical tests (such as liver function) may be done while you are taking this product. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. Keep all medications and herbal products away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.