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This form is not intended for use in reporting adverse events related to Tris medicines. You may report such events by calling 1-732-940-0358 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch, where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense or use. Visit MedWatch or call 1-800-FDA-1088.