Black Cohosh Root Extract Oral tablet

What is this medicine?

BLACK COHOSH (blak KOH hosh) or Cimicifuga racemosa is a dietary supplement. It is being promoted to help support female health problems, like the symptoms of menopause (hot flashes). Black cohosh is also promoted to ease menstrual pain or pre-menstrual syndrome (PMS). The FDA does not recognize black cohosh as being safe or effective for any use at this time, and warns against its use in pregnancy.

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

What should I tell my health care provider before I take this medicine?

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

• cancer

• endometriosis or uterine fibroids

• high blood pressure

• infertility

• kidney disease

• liver disease

• menstrual changes or irregular periods

• unusual vaginal or uterine bleeding

• an unusual or allergic reaction to black cohosh, soybeans, tartrazine dye (yellow dye number 5), other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this herb by mouth with a glass of water. Follow the directions on the package labeling, or talk to your health care professional. Do not use for longer than 6 months without the advice of a health care professional. Do not use if you are pregnant or breast-feeding. Talk to your obstetrician-gynecologist or certified nurse-midwife.

This herb is not for use in children under the age of 18 years.

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 medicine?

• female hormones, like estrogens or progestins and birth control pills

• fertility treatments

• medicines for blood pressure

• medicines for diabetes

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 medicine?

Since this herb is derived from a plant, allergic reactions are possible. Stop using this herb if you develop a rash. You may need to see your health care professional, or inform them that this occurred. Report any unusual side effects promptly.

If you are taking this herb for menstrual or menopausal symptoms, visit your doctor or health care professional for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam while on this therapy. Follow the advice of your doctor or health care professional.

If you have any reason to think you are pregnant, stop taking this herb at once and contact your doctor or health care professional.

Herbal or dietary supplements are not regulated like medicines. 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 medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• difficulty breathing, shortness of breath, or wheezing

• easy bruising

• fast heartbeat, slow heartbeat, or palpitations

• headache

• high blood pressure

• severe nausea or vomiting

• unusually weak or tired

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

• heartburn

• mild 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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees C). Throw away any unused herb after the expiration date.