July 1997 Dear Doctor: This letter is to inform you about a recent change in the product labeling for CLARITIN-D 24 HOUR (10 mg loratadine/240 mg pseudoephedrine sulfate, USP) Extended Release Tablets. This labeling change could impact your prescribing for a small portion of your patient population. You should be aware that there have been rare postmarketing reports of mechanical upper gastrointestinal tract obstruction in patients taking CLARITIN-D 24 HOUR. For some of these patients, an endoscopy was required to remove the tablet. In most of these cases, patients have had a history of difficulty in swallowing tablets or have had known upper gastrointestinal narrowing or abnormal esophageal peristalsis. Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use this product. For these patients, you may want to consider prescribing CLARITIN-D 12 HOUR (5 mg loratadine/120 mg pseudoephedrine sulfate, USP) Extended Release Tablets instead of CLARITIN-D 24 HOUR. Also, as with many tablets, please remind patients that CLARITIN-D 24 HOUR should be taken with a glass of water. You can further our understanding of adverse events by reporting all cases to Schering-Plough at 1-800-526-4099 or to the FDA MedWatch program by phone 1-800-FDA-1088, by FAX at 1-800-FDA-0178, or by mail: MedWatch, HF-2 FDA 5600 Fishers Lane Rockville, MD 20857 Again, we remind you that the labeling for CLARITIN-D 24 HOUR has changed due to rare postmarketing reports of mechanical upper gastrointestinal tract obstruction in patients taking CLARITIN-D 24 HOUR. Please review the highlighted changes of the labeling presented in the adjacent italicized text. Also, please see the enclosed full prescribing information. Sincerely, Alan G. Harris, MD Director, Medical & Scientific Affairs

PRECAUTIONS: Information for Patients: Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use this product. ADVERSE REACTIONS: There have been rare postmarketing reports of mechanical upper gastrointestinal tract obstruction in patients taking CLARITIN-D 24 HOUR Extended Release Tablets. In most of these cases, patients have had a history of difficulty in swallowing tablets or have had known upper gastrointestinal narrowing or abnormal esophageal peristalsis. DOSAGE AND ADMINISTRATION: Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use this product.

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