Melatonin Prolonged-Release Bisect - 3 mg- 180 tab

DescriptionMelatonin P.R. 3 mg.,180 Prolonged-Release Bisect Tablet Dr. Mark's® Each Prolonged-Release Bisect Tablet Contains: Melatonin (purest pharmaceutical grade) In a proprietary-designed polymeric base formulated to release over a 6 to 8 hour period 3 mg. Suggested Usage: Adults take 1 tablet 1 hour before bedtime as directed by physician onlQuality You Can Trust! Here at Dr. Mark's® , there is no greater mission than assuring that each and every supplement produced is of the highest quality. When you see the Dr. Mark's® ÔQuality Brand be assured that only the finest raw materials are being used, and that all manufacturing is performed under the strictest of guidelines. Because these products are developed specifically for exclusive distribution by healthcare professionals, our emblem has become a recognized symbol of quality that patients around the world have come to rely upon and trust. Manufacturing Practices and Certifications Dr. Mark's® rigid manufacturing practices and procedures are designed to monitor and verify quality throughout every step of the production process. cGMPs (current Good Manufacturing Practices) in accordance with USPXXVI SOPs (written Standard Operating Procedures) in accordance with cGMPs VCP (Vendor Certification Program) ensuring raw material quality ISO 9001 and ISO 17025 accreditation/in-house laboratory certification In-house Ôuniversity? training and ongoing educational program In-House Laboratories Ensure Overall Product Quality Our in-house laboratories, under the supervision of our staff Ph.D.s, constantly monitor quality. From raw materials entering our facility through testing dosage potency and tablet/capsule disintegration, our in-house labs ensure product quality and consistency. Chemical Analysis Laboratory ? ensuring potency of formula components Physical Analysis Laboratory ? ensuring dosage weight, hardness, disintegration, and overall consistency and appearance Microbiology Laboratory ? testing all raw materials and products for yeast, mold, and bacterial purity in accordance with USPXXVI ISO 9001 Certification and ISO 17025 Accreditation Douglas Laboratories is proud to announce that our in-house laboratory certification and accreditation meet both the ISO 9001 and ISO 17025 standards. These standards mean that we are compliant with one of the highest and most recognized standards of quality in the world. When comparing supplement suppliers, ask them for verification of their laboratories? ISO certification. Facilities? International Regulatory Compliance Our world-class manufacturing facilities comply with federal and other worldwide regulatory bodies. FDA Canadian Ministry of Health European Ministry of Health Melatonin P.R. DESCRIPTION Melatonin P.R.tablets, provided by Dr. Mark's® contain 3 mg of purest pharmaceutical grade melatonin, in a prolonged-release, bisected tablet. FUNCTIONS Melatonin is a natural hormone nutrient that is synthesized from the amino acid tryptophan by the pineal gland in the back of the brain. Melatonin also occurs in small amounts in a variety of foods. In the body, melatonin appears to regulate sleep/wake cycles, support normal immune function, and protect cells from free radical damage. Most of the research on melatonin has focused on its role in maintaining normal sleep/wake rhythms. The perception of daylight in the eyes is a signal for the pineal gland to inhibit melatonin synthesis and release. At night or in the dark, the body?s melatonin production rises. The rise in plasma melatonin is thought to be responsible for bringing on sleep. Nocturnal melatonin production is highest in children and begins to decline from adolescence on until it is virtually absent in the elderly. Melatonin supports normal immune function by helping maintain the activity of circulating natural killer cells. It also has been found to function as an antagonist for stress-induced immunosuppression. Melatonin is considered a potent antioxidant that enters all body cells to help prevent free radical damage. In the brain, melatonin is perhaps the most important physiological antioxidant. Due to its lipid and watersoluble properties, it can freely cross the blood-brain barrier. In vitro studies show that melatonin is more effective than glutathione in scavenging toxic hydroxyl radicals, and also more efficient than vitamin E in neutralizing peroxyl radicals which can induce DNA damage. Furthermore, melatonin stimulates the main antioxidant enzyme of the brain, glutathione peroxidase. INDICATIONS Melatonin P.R. tablets may be a useful dietary supplement for individuals wishing to supplement their diet with melatonin. Each Tablet Contains: Melatonin.........................................................3 mg SUGGESTED USE Adults take 1 tablet 1 hour before bedtime as directed by physician only. SIDE EFFECTS Not to be taken by individuals under the age of 18. If you are pregnant, nursing, taking any prescription medication (especially hormone replacement therapy), or have an autoimmune or depressive disorder consult a physician before using this product. Long-term use of melatonin has not been studied. Use of this product could cause hypothermia. Do not use before or while operating a motor vehicle or heavy machinery. STORAGE Store in a cool, dry place, away from direct light. Keep out of reach of children. REFERENCES Alvarez B, Dahlitz M, Vignau J, Parkes JD: The delayed sleep phase syndrome: Clinical and investigative findings in 14 patients. J Neurol Neurosurg Psychiatry 1992;55:665-670. Armstrong SM, Redman JR: Melatonin: A chronobiotic with antiaging properties? Med Hypotheses 1991;34:300-309. Beck-Friis J, Kjellman BF, Aperia B et al: Serum melatonin in relation to clinical variables in patients with major depressive disorder and a hypothesis of a low melatonin syndrome. Acta Psychiatr Scand 1985;71:319-330. Bismar K, Morgensen L, Wetterberg L: Depressed melatonin secretion in patients with nightmares due to beta-adrenoceptor blocking drug. Acta Med Scand 1987;221:155-158. Dahlitz M, Alvarez B, Vignau J et al: Delayed sleep phase syndrome response to melatonin. Lancet 1991;337:1121-1124. Lieberman HR: Behavior, sleep and melatonin. J Neural Transm Suppl 1989;21:233-241. Lissoni P, Barni S, Cattaneo G et al: Clinical results with the pineal hormone melatonin in advanced cancer resistant to standard antitumor therapies. Oncology 1991;48:448-450. (continued on reverse) These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Manufactured for Dr. Mark's® By: Douglas Laboratories 600 Boyce Road Pittsburgh, PA 15205