1 INDICATIONS AND USAGE Methylphenidate hydrochloride oral solution is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older Narcolepsy Methylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older (1 ) Narcolepsy ( 1 )

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [ see Warnings and Precautions (5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution [ see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [ see Contraindications ( 4 ), Drug Interactio ns ( 7 )] Risks to patient with serious cardiac disease [ see Warnings and Precautions ( 5.2 )] Increased blood pressure and heart rate [ see Warnings and Precautions ( 5.3 )] Psychiatric adverse reactions [ see Warnings and Precautions ( 5.4 )] Priapism [ see Warnings and Precautions ( 5.5 )] Peripheral vasculopathy, including Raynaud's phenomenon [ see Warnings and Precautions ( 5.6 )] Long-term suppression of growth in pediatric patients [ see Warnings and Precautions ( 5.7 )] Acute angle closure glaucoma [see Warnings and Precautions ( 5.8 )] Increased intraocular pressure and glaucoma [see Warnings and Precautions ( 5.9 )] Motor and verbal tics, and worsening of Tourette's syndrome [see Warnings and Precautions ( 5.10 )] The following adverse reactions associated with the use of methylphenidate containing products were identified in clinical studies, postmarketing reports, or literature.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and infestations : nasopharyngitis Blood and the lymphatic system disorders : leukopenia, thrombocytopenia, anemia, pancytopenia Immune system disorders : hypersensitivity reactions, including angioedema and anaphylaxis, auricular swelling, bullous conditions, eruptions, exanthemas Metabolism and nutrition disorders : decreased appetite, reduced weight gain and suppression of growth during prolonged use in pediatric patients Psychiatric disorders : insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood, affect lability, mania, disorientation, libido changes Nervous system disorders : headache, dizziness, tremor, dyskinesia including choreoatheetoid movements, drowsiness, convulsions, cerebral arteritis and/or occlusion, serotonin syndrome in combination with serotonergic drugs, migraine Eye disorders : blurred vision, difficulties in visual accommodation, diplopia, mydriasis Cardiac disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris, sudden cardiac death, myocardial infarction, bradycardia, extrasystole Respiratory, thoracic and mediastinal disorders: cough, pharyngolaryngeal pain, dyspnea Gastrointestinal disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia, diarrhea General disorders: fatigue, hyperpyrexia Hepatobiliary disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury Skin and subcutaneous tissue disorders : hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura angioneurotic edema, erythema, fixed drug eruption Musculoskeletal and connective tissue disorders : arthralgia, muscle cramps, rhabdomyolysis, myalgia, muscle twitching Renal and urinary disorders : hematuria Reproductive system and breast disorders : gynecomastia Urogenital disorders : priapism Vascular disorders : peripheral coldness, Raynaud's phenomenon Investigations : weight loss Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain.

(6) To report SUSPECTED ADVERSE REACTIONS contact Lupin Pharmaceuticals, Inc.

at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.