Red yeast rice has been used for lowering cholesterol levels.

Some 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. Ask your doctor or pharmacist for more details.

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

Avoid eating grapefruit or drinking grapefruit juice while using this product unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this product. Ask your doctor or pharmacist for more details.

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

Abdominal/stomach pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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

• muscle pain/tenderness/weakness (especially with fever or unusual tiredness)
• signs of kidney problems (such as change in the amount of urine)
• signs of liver problems (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain, yellowing eyes/skin, dark urine)

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 this product, 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:

• liver disease
• kidney disease
• alcohol use

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

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this product. Ask your doctor or pharmacist for more information.

Red yeast rice must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this product passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this product. 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:

• azole antifungals (such as itraconazole, ketoconazole)
• "blood thinners" (such as warfarin)
• macrolide antibiotics (such as erythromycin, clarithromycin)
• nefazodone
• ritonavir
• telithromycin

Some red yeast rice products may also contain a "statin" cholesterol-lowering drug called lovastatin. Taking too much of a statin can increase your risk of serious side effects (such as muscle and liver problems). Since you may not know if your product contains lovastatin, do not take any red yeast rice products if you are also taking any statin drugs (such as atorvastatin, lovastatin, simvastatin).

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.

Keep all medical and lab appointments.

A low-cholesterol/low-fat diet and exercise are important parts of controlling cholesterol levels and decreasing your risk of heart disease. Consult your doctor for more details.

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.