dextroamphetamine saccharate amphetamine aspartate dextroamphetamine sulfate and amphetamine sulfate tablet
INDICATIONS AND USAGE Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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.
Epic Pharma LLC
ROUND BLUE logo 341
logo 341 ROUND BLUE
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HOW SUPPLIED
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablets (Mixed Salts of a Single Entity Amphetamine Product) is supplied as follows: 5 mg: blue, round flat-faced beveled edge tablets, debossed "є" above "339" on one side and quadrisect on the other side. They are available in bottles of 100 tablets (NDC 42806-339-01). 10 mg: blue, round biconvex tablets, debossed “ є ” above “ 341 ” on one side and quadrisect on the other side. They are available in bottles of 100 tablets (NDC 42806-341-01) 15 mg: pink, oval-shaped tablets, debossed " є343" on one side and a full and partial bisect on the other side. They are available in bottles of 100 tablets (NDC 42806-343-01) 20 mg: pink, round biconvex tablets, debossed “ є ” above “ 344 ” on one side and quadrisect on the other side. They are available in bottles of 100 tablets (NDC 42806-344-01). 30 mg: pink, round flat-faced beveled edge tablets, debossed "є" above "345" on one side and quadrisect on the other side. They are available in bottles of 100 tablets (NDC 42806-345-01). Dispense in a tightly-closed, 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]. Dispense with Medication Guide available at: www.epic-pharma.com/medguide/Dextroamp-Saccharate-Amp-Asparate-Dextroamp-Sulfate-Amp-Sulfate-Tablet.pdf Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev.09/2023 MF339REV09/2023 OE2729
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