Limbrel

Limbrel

INDICATIONS

Recommended Use

LIMBREL (flavocoxid) is intended for the clinical dietary management of the metabolic processes of osteoarthritis (OA).

Disclaimed Use

LIMBREL (flavocoxid) has not been investigated for use in the clinical dietary management of rheumatoid arthritis (RA), acute pain or primary dysmenorrhea.

DOSAGE AND ADMINISTRATION

Recommended Administration

For the clinical dietary management of the metabolic processes of OA, take either one 250 mg or one 500 mg capsule every 12 hours for 500 mg to 1,000 mg total daily consumption as directed by a physician. LIMBREL (flavocoxid) is safe taken with or without other foods. If patients forget to take the prescribed amount, take it as soon as they remember and then resume the normal schedule as directed by a physician.

HOW SUPPLIED

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:

#. Size
68040-601-16 Bottle of 60 capsules (250 mg)
68040-601-18 Carton of 120 capsule (250 mg) packets containing 20 packs of 6-capsule packets each as a sample package (Not For Resale)
68040-601-12 Carton of 20 capsule (250 mg) packets containing 1 capsule each as a sample package (Not For Resale)
68040-601-13 Carton of 20 capsule (250 mg) blister cards containing 2 capsules each as a sample package (Not For Resale)
68040-601-02 Blister Card of 2 capsules (250 mg) as a sample (Not For Resale)
68040-601-01 Packet of 1 capsule (250 mg) as a sample (Not For Resale)

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:

# Size
68040-602-16 Bottle of 60 capsules (500 mg)
68040-602-12 Carton of 20 capsule (500 mg) packets containing 1 capsule each as a sample package (Not For Resale)
68040-602-01 Packet of 1 capsule (500 mg) as a sample (Not For Resale)

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

Last reviewed on RxList: 7/24/2008
This monograph has been modified to include the generic and brand name in many instances.

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