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Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Amphetamine aspartate 7.5 MG Amphetamine Sulfate 7.5 MG Dextroamphetamine saccharate 7.5 MG Dextroamphetamine Sulfate 7.5 MG Oral Tablet

INDICATIONS AND USAGE Mixed Salts of a Single Entity Amphetamine Product are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV ® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. 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. 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 the required number of DSM-IV ® characteristics. Need for Comprehensive Treatment Program – Mixed Salts of a Single Entity Amphetamine Product are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be 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 other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. 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. Long-Term Use – The effectiveness of Mixed Salts of a Single Entity Amphetamine Product for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Mixed Salts of a Single Entity Amphetamine Product for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Mallinckrodt, Inc.


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5 years ago OCTAGON WHITE M 30 Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate  Amphetamine aspartate 7.5 MG  Amphetamine Sulfate 7.5 MG  Dextroamphetamine saccharate 7.5 MG  Dextroamphetamine Sulfate 7.5 MG Oral Tablet

OCTAGON WHITE M 30

5 years ago OCTAGON WHITE M 30 Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate  Amphetamine aspartate 7.5 MG  Amphetamine Sulfate 7.5 MG  Dextroamphetamine saccharate 7.5 MG  Dextroamphetamine Sulfate 7.5 MG Oral Tablet

M 30 OCTAGON WHITE

HOW SUPPLIED Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) are supplied as follows: 5 mg: white to cream colored/mottled pillow shaped tablet, debossed with a “5” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8891-01 7.5 mg: white to cream colored/mottled pillow shaped tablet, debossed with a “7.5” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8884-01 10 mg: white to cream colored/mottled pillow shaped tablet, debossed with a “10” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8892-01 12.5 mg: white to cream colored/mottled octagon shaped tablet, debossed with a “12.5” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8886-01 15 mg: white to cream colored/mottled octagon shaped tablet, debossed with a “15” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8885-01 20 mg: white to cream colored/mottled octagon shaped tablet, debossed with a “20” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8893-01 30 mg: white to cream colored/mottled octagon shaped tablet, debossed with a “30” and a partial quadrisect on one side and a on the other side. Bottles of 100….NDC 0406-8894-01 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt. Regitine and DSM-IV are trademarks of their respective owners. SpecGx LLC Webster Groves, MO 63119 USA Rev 08/2017 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20D11.pdf or by calling 1-800-778-7898 for alternate delivery options. Mallinckrodt Mallinckrodt Mallinckrodt Mallinckrodt Mallinckrodt Mallinckrodt Mallinckrodt Mallinckrodt

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