ACTION AND DESCRIPTIONDietary supplement. Melatonin helps reduce the time it takes to fall asleep.STORAGE AND EXPIRATION Store in a cool, dry place. Do not freeze and keep away from direct light and heat.INGREDIENTSFructose, purified water, melatonin, preservatives: potassium sorbate, sodium benzoate; flavorings; thickener: xanthan gum.Per dose: melatonin 1 mg.HOW TO USE4 drops a day.Take the recommended dose directly into the mouth or dilute in soft drinks. Take 30 minutes before going to sleep.Shake before use.OTHERAccording to the Report of the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) on the conditions of use of certain substances to be used in food supplements: MelatoninAECOSAN has proposed a maximum daily amount for melatonin of 1 mg. This proposal is based on the authorization of two health claims, in relation to melatonin contributing to• alleviating the subjective feeling of jet lag:It can only be used with foods that contain a minimum of 0.5 mg of melatonin per quantified portion. For a product to bear this claim, the consumer must be informed that the beneficial effect is obtained with a minimum intake of 0.5 mg to be taken shortly before going to bed on the first day of travel and a few days after arrival at the destination (EU, 2012). Melatonin contributes to reducing the time taken to fall asleep. Can only be used with foods containing 1 mg of melatonin per quantified portion. In order for a product to bear this claim, the consumer must be informed that the beneficial effect is obtained with an intake of 1 mg of melatonin shortly before going to sleep (EU, 2012). Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone produced by the pineal gland of mammals and other organs, especially the enterochromaffin cells of the gastrointestinal tract and the retina (Hardeland et al., 1993) (Huether, 1993), whose main physiological function is the regulation or control of circadian and seasonal rhythms (Armstrong et al., 1986). It was discovered in the 1950s (Lerner et al., 1958, 1959). In recent years it has been shown that melatonin also has numerous additional functions; it is produced and acts on numerous tissues or cells that express melatonin receptors, at much lower levels (Hardeland, 2009). Melatonin receptors MT1 and MT2 (membrane receptors) have been detected in numerous tissues of the CNS (Central Nervous System), in peripheral organs such as the gastrointestinal tract, liver, lung, skin, adrenal gland, gonads, male organs, breast tissue, kidney, heart, blood vessels, adipose tissue, neutrophils, lymphocytes and lymphoid tissue (Ishii et al., 2009). Both receptors involve signaling through cAMP inhibition, protein kinase A activity, effects on phospholipase A2 and C, and effects on potassium and calcium channels (Mathes, 2010). A third receptor, MT3, has also been described as an enzyme identified as quinone reductase 2. Deficiencies in melatonin production or in receptor expression or decreases in melatonin levels (such as those that occur with age) lead to numerous dysfunctions. In these cases, with insufficient melatonin levels or poor melatoninergic signaling, numerous pathophysiological alterations can occur, reflecting the pleiotropy of the molecule. Thus, for example, a decrease in nocturnal melatonin levels has been repeatedly observed in patients with neurodegenerative disorders and sleep disturbances (Uchida et al., 1996). PRECAUTIONS AND WARNINGS Do not exceed the recommended daily dose. Keep out of reach of children under 3 years of age. Should not be used as a substitute for a balanced diet. USE IN PATIENTS WITH FOOD INTOLERANCE This product can be taken by a person with celiac disease, who is allergic/intolerant to eggs, or who is intolerant to milk.