1 INDICATIONS AND USAGE Methylphenidate hydrochloride tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults Narcolepsy Methylphenidate hydrochloride is a centralnervoussystem(CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders(ADHD) and Narcolepsy(1).

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warningsand Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 ) ] Knownhypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride tablets [see Contraindications( 4 )] Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [seeContraindications ( 4 ), Drug Interactions ( 7.1 )] Serious Cardiovascular Reactions [see Warningsand Precautions ( 5.2 )] Blood Pressure and Heart Rate Increases [see Warnings and Precautions ( 5.3 )] Psychiatric Adverse Reactions [seeWarningsandPrecautions( 5.4 )] Priapism [seeWarningsand Precautions ( 5.5 )] Peripheral Vasculopathy, IncludingRaynaud’sPhenomenon [seeWarningsand Precautions ( 5.6 )] Long-Term Suppression of Growth [see Warnings and Precautions ( 5.7 )] The following adverse reactions associated with the use of methylphenidate hydrochloride tablets, and othermethylphenidate products were identified in clinical trials,spontaneous reports, and literature.

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

Adverse Reactions Reported With methylphenidate hydrochloride Infections andInfestations: nasopharyngitis Blood and the Lymphatic System Disorders : leukopenia, thrombocytopenia,anemia Immune System Disorders: hypersensitivity reactions, includingangioedema, and anaphylaxis Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolongeduse in pediatric patients Psychiatric Disorders: insomnia,anxiety, restlessness, agitation, psychosis(sometimes with visual and tactile hallucinations), depressed mood Nervous System Disorders: headache, dizziness, tremor, dyskinesia, including choreoatheetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs Eye Disorders: blurred vision, difficulties in visual accommodation Cardiac Disorders: tachycardia,palpitations, increased blood pressure, arrhythmias, angina pectoris Respiratory, Thoracic, and Mediastinal Disorders: cough Gastrointestinal Disorders: dry mouth, nausea, vomiting,abdominal pain, dyspepsia Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury Skin andSubcutaneousTissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythemamultiforme rash, thrombocytopenic purpura Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis Investigations: weight loss (adult ADHD patients) Additional Adverse Reactions Reported with Other Methylphenidate-ContainingProducts The list below shows adverse reactions not listed for methylphenidate hydrochloride tablets that have been reported with other methylphenidate-containingproducts.

Blood and Lymphatic Disorders: pancytopenia Immune System Disorders: hypersensitivity reactions, such as auricular swelling, bullous conditions, eruptions, exanthemas Psychiatric Disorders: affect lability, mania,disorientation, and libido changes Nervous System Disorders: migraine Eye Disorders: diplopia, mydriasis Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole Vascular Disorders: peripheral coldness, Raynaud'sphenomenon Respiratory, Thoracic, and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea Gastrointestinal Disorders: diarrhea, constipation Skin andSubcutaneousTissue Disorders: angioneuroticedema,erythema, fixed drug eruption Musculoskeletal, Connective Tissue, and Bone Disorders: myalgia,muscle twitching Renal and Urinary Disorders: hematuria Reproductive System and Breast Disorders: gynecomastia General Disorders: fatigue, hyperpyrexia Urogenital Disorders : priapism Commonadverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.