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FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults
Date:6/27/2008

enidate or other ingredients in CONCERTA(R); significant anxiety, tension, or agitation; glaucoma; tics, Tourette's syndrome, or family history of Tourette's syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under six years of age should not take CONCERTA(R).

Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs; has had any heart problems, heart defects, high blood pressure, or a family history of these problems; has had depression, abnormal thoughts or visions, bipolar disorder, or seizure. Contact your healthcare professional immediately if you or your child: develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity; or if aggressive behavior or hostility develops or worsens while taking CONCERTA(R).

Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that CONCERTA(R) does not adversely affect your ability to engage in such activities.

The most common adverse reaction (> 5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.

Visit http://www.concerta.net/concerta/pages/full.jsp for complete prescribing information.

About McNeil Pediatrics

McNeil Pediatrics(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to meeting the needs of pediatric medicine through the development of therapies specifically formulated for children. McNeil Pediatrics markets CONCERTA(R) for the treatment of children, adolescents and adults with ADHD in the United States. McNeil Pediatrics continues
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SOURCE Johnson & Johnson Pharmaceutical Research & DevelopmentL.L.C.
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