dextroamphetamine saccharate amphetamine aspartate dextroamphetamine sulfate and amphetamine sulfate 30 mg
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.
granules pharmaceuticals inc.
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HOW SUPPLIED 5 mg: white to off white, oval shaped, biconvex tablets, double scored on one side and debossed with “G 5†above “111†on other side. Bottles of 30 Tablets NDC 70010-111-03 Bottles of 100 Tablets NDC 70010-111-01 7.5 mg: white to off white, round, flat faced, beveled edge tablets, double scored on one side and debossed with “G 7.5†above “112†on other side. Bottles of 30 Tablets NDC 70010-112-03 Bottles of 100 Tablets NDC 70010-112-01 10 mg: white to off white, oval shaped, flat faced, beveled edge tablets, double scored on one side and debossed with “G 10†above “113†on other side. Bottles of 30 Tablets NDC 70010-113-03 Bottles of 100 Tablets NDC 70010-113-01 12.5 mg: white to off white, oval shaped, biconvex tablets, double scored on one side and debossed with “G 12.5†above “114†on other side. Bottles of 30 Tablets NDC 70010-114-03 Bottles of 100 Tablets NDC 70010-114-01 15 mg: white to off white, round, flat faced, beveled edge tablets, double scored on one side and debossed with “G 15†above “115†on other side. Bottles of 30 Tablets NDC 70010-115-03 Bottles of 100 Tablets NDC 70010-115-01 20 mg: white to off white, oval shaped, flat faced, beveled edge tablets, double scored on one side and debossed with “G 20†above “116†on other side. Bottles of 30 Tablets NDC 70010-116-03 Bottles of 100 Tablets NDC 70010-116-01 30 mg white to off white, oval shaped, biconvex tablets, double scored on one side and debossed with “G 30†above “117†on other side. Bottles of 30 Tablets NDC 70010-117-03 Bottles of 100 Tablets NDC 70010-117-01 Dispense in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense with Medication Guide available at: https://granulespharma.com/product/mixed-salts-amphetamine-tab/ Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Rev. 06/2024
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