Methylphenidate Hydrochloride 5 MG Chewable Tablet
INDICATIONS AND USAGE Attention Deficit Disorders, Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride chewable tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.
camber pharmaceuticals inc
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HOW SUPPLIED Each
METHYLPHENIDATE HYDROCHLORIDE chewable tablet 2.5 mg is available as a white to off-white round beveled edge chewable tablets debossed with '260' on one side and 'AT' on the other side. Bottles of 100 NDC 31722-926-01 Each
METHYLPHENIDATE HYDROCHLORIDE chewable tablet 5 mg is available as a white to off-white round beveled edge chewable tablets debossed with '261' on one side and 'AT' on the other side. Bottles of 100 NDC 31722-927-01 Each
METHYLPHENIDATE HYDROCHLORIDE chewable tablet 10 mg is available as a white to off-white flat round chewable tablets debossed with 'AT' on left side and '262' on the right side of the bisect line and other side plain. Bottles of 100 NDC 31722-928-01 Protect from moisture. Dispense in tight container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Ritalin ® is a registered trademark of Novartis Corporation. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 09/23
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