This product may rarely cause serious (possibly fatal) liver disease. Stop taking this product and consult your doctor right away if you develop symptoms of liver injury, including persistent nausea, loss of appetite, unusual tiredness, stomach/abdominal pain, pale stools, dark urine, yellowing eyes/skin. Using this product for a long time or in high doses, using certain other drugs that may harm the liver along with this product, current/previous liver problems, and drinking alcoholic beverages may increase your risk of serious liver problems. See also Drug Interactions section.Who should not take kava root?
Kava has been used for anxiety and stress. Germany, Switzerland, and Canada have banned products containing kava because of the risk of liver injury. The US 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 are uncertain about any of the information, consult your doctor or pharmacist.
This herbal product should not be used for more than 3 months at a time.
If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.
See also Warning section.
Tell your doctor right away if any of these unlikely but serious side effects occur: 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. Seek immediate medical attention if you develop yellow eyes/skin.
A very serious allergic reaction to this product is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.
This product may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages because alcohol may worsen these effects and increase the risk of serious liver problems.
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.
Kava is not recommended for use during pregnancy. Consult your doctor before using this product.
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: alprazolam, drugs that can harm the liver (e.g., acetaminophen, amiodarone, carbamazepine, isoniazid, methotrexate, methyldopa, "statins" such as atorvastatin and lovastatin), "blood thinners" (e.g., warfarin).
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that may make you drowsy. 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, inability to move.
Tell your doctor that you are taking kava. Keep all regular medical and laboratory appointments. Your doctor may order liver function tests to check for side effects.
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 and resume your usual dosing schedule. 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 for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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