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warnings
WARNINGS Reye Syndrome is a rare but serious disease which may develop in children and teenagers who have chicken pox, influenza, or flu symptoms. While the cause of Reye Syndrome is unknown, some studies suggest a possible association between the development of Reye Syndrome and the use of medicines containing acetylated salicylates or aspirin. Choline Magnesium Trisalicylate Liquid is a combination of choline salicylate and magnesium salicylate which are nonacetylated salicylates, and there have been no reported cases associating Choline Magnesium Trisalicylate Liquid with Reye Syndrome. Nevertheless, Choline Magnesium Trisalicylate Liquid, as a salicylate-containing product, is not recommended for use in children and teenagers with chicken pox, influenza or flu symptoms. The FDA has determined that routine heavy alcohol use (three or more alcoholic drinks every day), in combination with analgesic/antipyretic drug products containing NSAID ingredients (including choline and magnesium salicylates), increases the risk of adverse GI events, including stomach bleeding.
ADVERSE REACTIONS The most frequent adverse reactions observed with Choline Magnesium Trisalicylate Liquid in clinical trials 7-12 are tinnitus and gastrointestinal complaints (including nausea, vomiting, gastric upset, indigestion, heartburn, diarrhea, constipation and epigastric pain). These occur in less than twenty percent (20%) of patients. Should tinnitus develop, reduction of daily dosage is recommended until the tinnitus is resolved. Less frequent adverse reactions, occurring in less than two percent (2%) of patients, are: hearing impairment, headache, lightheadedness, dizziness, drowsiness, and lethargy. Adverse reactions occurring in less than one percent (1%) of patients, are: gastric ulceration, positive fecal occult blood, elevation in serum BUN and creatinine, rash, pruritus, anorexia, weight gain, edema, epistaxis and dysgeusia. Spontaneous reporting has yielded isolated or rare reports of the following adverse experiences: duodenal ulceration, elevated hepatic transaminases, hepatitis, esophagitis, asthma, erythema multiforme, urticaria, ecchymoses, irreversible hearing loss and/or tinnitus, mental confusion and hallucinations.