Natrol (also known as SAMe) is a man-made form of a chemical that occurs naturally in the body.

SAMe is likely effective in alternative medicine as an aid in treating osteoarthritis.

SAMe has been used in alternative medicine as a possibly effective aid with itching, tiredness, and abnormal lab tests in people with liver disease, and improving symptoms in people with depression.

Other uses not proven with research have included treating alcohol-related liver disease, schizophrenia, aging, Alzheimer disease, fibromyalgia, chronic back pain, migraine headaches, seizures, premenstrual syndrome, and chronic fatigue syndrome.

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

SAMe 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.

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

You should not use SAMe if you have bipolar depression, anxiety disorder, or take medicine for depression.

Do not use SAMe if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

When considering the use of SAMe, 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 SAMe, 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.

SAMe should be taken on an empty stomach, at least 30 to 60 minutes before a meal or two hours after a meal.

Call your doctor if your symptoms do not improve, or if they get worse.

If you need surgery, stop taking SAMe at least 2 weeks ahead of time.

Store at room temperature away from moisture and heat.

You should not use SAMe if you have bipolar disorder (manic depression), anxiety disorder, or take antidepressant medications.

Do not use SAMe if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with SAMe could cause a serious condition called serotonin syndrome.

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

• a planned surgery;

• Lesch-Nyhan syndrome; or

• Parkinson's disease.

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

SAMe is considered likely unsafe to use if you are nursing a baby. Do not use this product without medical advice if you are breastfeeding a baby.

Do not give any herbal/health supplement to a child without medical advice.

Skip the missed dose and take the next regularly scheduled dose.

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

Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Although not all side effects are known, SAMe is thought to be likely safe for most adults when used as directed.

Common side effects of Natrol may include:

• changes in hair color;

• headache, dizziness;

• feeling anxious or nervous;

• loss of appetite, vomiting, nausea, upset stomach;

• dry mouth;

• diarrhea, constipation;

• increased sweating; or

• sleep problems (insomnia).

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.