"On April 3, 2015, the U.S. District Court for the District of Massachusetts on behalf of the U.S. Food and Drug Administration has filed a consent decree of permanent injunction against Michael P. Ferry Inc., a dairy operation located in Westport"...
FOLTX (folacin, cyanocobalamin & pyridoxine) tablets are indicated for the distinct nutritional requirements of individuals under a physician's treatment for hyperhomocysteinemia; with particular emphasis for individuals with or at risk for atherosclerotic vascular disease in the coronary1, peripheral2, or cerebral3 vessels, or vitamin B12 deficiency4.
DOSAGE AND ADMINISTRATION
Usual adult dose is one to two tablets daily or as directed by a physician.
Available as a round coated beige colored tablet. Debossed with "PAL" on one side and (heart outline) on the other. Supplied in bottles of 90 tablets.
Store at controlled room temperature between 15° -30°C (59° -86°F) (See USP). Protect from light and moisture. Dispense in original light-resistant container with child resistant closure.
1,2 Eilelboom JW, Lonna Eva, Genest Jr Jaques, Hankey Graeme, Yusuf Salim: Homocysteine and Cardiovascular Disease: A Critical Review of the Epidemiologic Evidence. Ann Intern Med. 1999; 131:363-375.
3 The Homocysteine Studies Collaboration: Homocysteine and Risk of Ischemic Heart Disease and Stroke. JAMA 2002; Vol 288, No. 16:2015-2002.
4 Refsum Helga, Smith A. David, Ueland Per M, Nexo Ebba, Clarke Robert, McPartlin Joseph, Johnston Carole, Engbaek Frode, Scheede Jorn, McPartlin Catherime, and Scott John M.: Facts and Recommendations about Total Homocysteine Determinations: An Expert Opinion. Clinical Chemistry 2004; 50:1 3-32.
Manufactured For PAMLAB, L.L.C. Covington, LA. Revised 03/07. FDA Rev date: n/a
Last reviewed on RxList: 6/30/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Foltx Information
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