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.
Mallinckrodt, Inc.
OCTAGON WHITE M 30
M 30 OCTAGON WHITE
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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. © 2023 Mallinckrodt. DSM-IV and Evekeo are trademarks of their respective owners. Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA Rev 10/2023 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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