Dextroamphetamine saccharate amphetamine aspartate dextroamphetamine sulfate and amphetamine sulfate Amphetamine aspartate 5 MG Amphetamine Sulfate 5 MG Dextroamphetamine saccharate 5 MG Dextroamphetamine Sulfate 5 MG Oral 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.
Caraco Pharmaceutical Laboratories, Ltd.
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HOW SUPPLIED Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg, green, round, flat faced beveled edge tablet debossed with ‘MP441’ and two partial bisects on one side and plain on the other side Bottles of 100 NDC 57664-641-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 7.5 mg, green, oval, biconvex tablet debossed with ‘MP442’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-642-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 10 mg, green, round, biconvex tablet debossed with ‘MP443’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-643-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 12.5 mg, yellow, round-shaped, flat face beveled edge tablet, debossed with ‘MP444’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-644-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 15 mg, yellow, oval-shaped, biconvex tablet, debossed with ‘MP445’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-645-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 20 mg, yellow, round-shaped, biconvex tablet, debossed with ‘MP446’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-646-08 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 30 mg, yellow, round, flat faced beveled edge tablet, debossed with ‘MP447’, bisect and partial bisect on one side and plain on the other side Bottles of 100 NDC 57664-647-08 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESIStanT CONTAINER. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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