What is this medication?

KAVA KAVA (KAH vuh KAH vuh) may support relaxation and sleep. The FDA has not evaluated this supplement for any medical use. It may contain ingredients not listed. Discuss all supplements you are taking with your care team. They can provide you with important safety information.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Frequently drink alcohol
• Liver disease
• Mental health conditions
• Substance use disorder
• An unusual or allergic reaction to kava kava, other herbs, plants, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this supplement by mouth with a glass of water. Follow the directions on the package labeling, or take as directed by your care team. For best results take this supplement with food. Do not take this supplement more often than directed.

Contact your care team about the use of this supplement in children. This supplement is not recommended for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Alcohol
• Barbiturate medications for seizures or sleep
• Leflunomide
• Medications for depression, anxiety, or psychotic disturbances
• Medications for sleep
• Methotrexate
• Muscle relaxants
• Narcotic pain relievers
• Riluzole
• Tacrine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

See your care team if your symptoms do not get better or if they get worse. Do not take this supplement for more than 4 weeks unless your care team tells you to. Long term use of this supplement has not been proven to be helpful and may be harmful.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this supplement affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this supplement. Avoid alcoholic drinks.

If you are scheduled for any medical or dental procedure, tell your care team that you are taking this supplement. You may need to stop taking this supplement before the procedure.

Herbal or dietary supplements are not regulated like medications. Rigid quality control standards are not required for dietary supplements. The purity and strength of these products can vary. The safety and effect of this dietary supplement for a certain disease or illness is not well known. This product is not intended to diagnose, treat, cure or prevent any disease.

The Food and Drug Administration suggests the following to help consumers protect themselves:

• Always read product labels and follow directions.
• Natural does not mean a product is safe for humans to take.
• Look for products that include USP after the ingredient name. This means that the manufacturer followed the standards of the US Pharmacopoeia.
• Supplements made or sold by a nationally known food or drug company are more likely to be made under tight controls. You can write to the company for more information about how the product was made.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness the day after use
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature or as directed on the package label. Protect from moisture. Throw away any unused supplement after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.