Flavocoxid

LIMBREL (flavocoxid) is supplied in 250 mg and 500 mg capsules. LIMBREL (flavocoxid) 250 mg capsules are in two-part turquoise green capsules with a smooth surface imprinted “LIMBREL (flavocoxid) ” on one end and “52001” on the other end, supplied as:

LIMBREL (flavocoxid) 500 mg capsules are in two-part turquoise green capsules with a smooth surface imprinted with two white stripes on the cap, and imprinted “LIMBREL (flavocoxid) ” and “52002” on the body, supplied as:

Store at room temperature, 59-86oF (15-30oC) [see USP Controlled Room Temperature]. Protect from light and moisture. LIMBREL (flavocoxid) is supplied to pharmacies in a recyclable plastic bottle with a child-resistant cap. Dispense in a light-resistant container as defined in the USP/NF with a child-resistant closure.

Dispensed by prescription.

Manufactured by: Cornerstone Research and Development Farmington, UT 84025 and PAL Laboratories Miami, FL 33172. Manufactured for: Primus Pharmaceuticals, Inc. Scottsdale, AZ 85251 1-480-483-1410. www.limbrel (flavocoxid) .com. Revised 0907. FDA revision date: n/a

Do not use this product if you are allergic to bioflavonoids or if you have:

Before using bioflavonoids, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use bioflavonoids if you have certain medical conditions.

Do not take bioflavonoids without first talking to your doctor if you are pregnant or planning a pregnancy. It is not known whether bioflavonoids will be harmful to an unborn baby.

Do not take bioflavonoids without first talking to your doctor if you are breast-feeding a baby. It is not known whether bioflavonoids will be harmful to a nursing infant.

Do not give any herbal/health supplement to a child without the advice of a doctor.

Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.02. Revision date: 12/15/2010.

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You should take flavocoxid one hour before or after the consumption of food

Dosing

The dose of flavocoxid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of flavocoxid. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules)
  • For rheumatoid arthritis:
    • Adults—250 milligrams (mg) every 12 hours.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of flavocoxid, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take flavocoxid or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to flavocoxid. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Osteoarthritis: A medical food for dietary management of the metabolic processes of osteoarthritis

Note: A medical food is formulated to be administered enterally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Medical foods are not drugs and, therefore, are not subject to any FDA regulatory requirements that specifically apply to drugs (eg, requirement for written/oral prescription prior to dispensing, premarket review or approval, proof of safety and efficacy).

Osteoarthritis: Oral: 250 to 500 mg (with or without zinc) every 12 hours

Store at 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

≥2%:

Cardiovascular: Hypertension, varicose veins

Dermatologic: Psoriasis

Gastrointestinal: Occult stools (statistically similar to placebo)

Neuromuscular & skeletal: Fluid on the knee

Postmarketing and/or case reports (Limited to important or life-threatening): Hepatotoxicity (idiosyncratic) (Chalasani, 2014), jaundice, liver injury

Concerns related to adverse effects:

• Hepatic effects: Notable elevations of ALT and AST (approximately >3 to 5 times ULN) occurred in clinical trials in <2% of subjects; rare cases of severe hepatic reactions accompanied by jaundice or eosinophilia have been reported (cases resolved within 2 to 4 weeks after discontinuation). Discontinue immediately if abnormal liver function tests persist or worsen, if clinical signs/symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash, abdominal pain, diarrhea, dark urine).

Disease-related concerns:

• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal disorders.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.