Flavocoxid oral capsule

What is this medication?

FLAVOCOXID is a prescription dietary supplement. It is promoted for use in osteoarthritis ('wear-and-tear' of the joints). Use of this product is not recommended. Contact your health care provider if you have questions. Serious side effects have been reported. If you have experienced any side effects or health problems while taking this product, work with your health care provider to report your symptoms to the FDA.

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

COMMON BRAND NAME(S): Limbrel, LIMBREL250, LIMBREL500, LIMBREL525

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

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

• fluid retention in ankles or legs
• heart disease
• high blood pressure
• history of blood clots
• history of stroke
• kidney disease
• liver disease
• rheumatoid arthritis
• stomach or intestinal ulcers
• an unusual or allergic reaction to flavocoxid, flavonoids, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew. You may take this medicine with or without food. It may be best to take this medicine on an empty stomach, at least 1 hour before or 1 hour after meals. If it upsets your stomach, take it with food. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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?

Contact your health care provider. Do not take double or extra doses.

What may interact with this medication?

• aspirin or aspirin-like products
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• warfarin

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?

It is recommended that you do not take this product. Contact your health care provider if you have questions. Serious side effects have been reported. If you have experienced any side effects or health problems while taking this product, work with your health care provider to report your symptoms to the U.S. Food and Drug Administration (FDA).

This medical food is a combination of different nutrients found in fruits, plants, and vegetables. It has more of these nutrients than the normal American diet usually has. Taking a supplement does not replace the need for a balanced diet. Follow a healthy diet and exercise program.

What side effects may I notice from receiving this medication?

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
• breathing problems
• cough
• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on skin; unusual bruising or bleeding
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

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

• nausea
• upset stomach upset

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.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine 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.