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 are uncertain about any of the information, ask your doctor or pharmacist.
Avoid eating grapefruit or drinking grapefruit juice while using this product unless your doctor instructs you otherwise. Grapefruit can increase the amount of this product in your bloodstream. Consult your doctor or pharmacist for more details.
If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.
Abdominal/stomach pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Tell your doctor immediately if you have any of these rare but serious side effects: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine, signs of liver problems (such as severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine).
A very serious allergic reaction to this product is rare. However, seek immediate medical attention 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.
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.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
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 immediately.
It is unknown if this product passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using 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), delavirdine, macrolide antibiotics (such as erythromycin, clarithromycin), nefazodone, HIV protease inhibitors (such as 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).
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Keep all regular medical and laboratory 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 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.
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 February 2014. Copyright(c) 2014 First Databank, Inc.
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