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Reference ID: 4036863

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA . CONCERTA (methylphenidate HCl) Extended-Release Tablets CII Initial Approval: 2000 WARNING: DRUG DEPENDENCE See full prescribing information for complete boxed warning. CONCERTA should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence, with varying degrees of abnormal behavior.

Raynaud’s Phenomenon 5.6 Long-Term Suppression of Growth. 5.7 Visual Disturbance. 5.8 Potential for Gastrointestinal Obstruction. 5.9 Hematologic Monitoring. 6 ADVERSE REACTIONS 6.1. Commonly Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials 6.2 Other Adverse Reactions Observed in . CONCERTA Clinical Trials 17

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