dextroamphetamine saccharate amphetamine aspartate monohydrate dextroamphetamine sulfate and amphetamine sulfate capsule extended release
1 INDICATIONS AND USAGE Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. ( 1 ) 1.1 Attention Deficit Hyperactivity Disorder Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older.
ani pharmaceuticals, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsules 5 mg are hard gelatin capsules, green opaque cap and clear body, printed “AMG” on cap and “277” on body, which are supplied as follows: Bottles of 100 NDC 43975-277-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsules 10 mg are hard gelatin capsules, green opaque cap and body, printed “AMG” on cap and “278” on body, which are supplied as follows: Bottles of 100 NDC 43975-278-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsules 15 mg are hard gelatin capsules, green opaque cap and white opaque body, printed “AMG” on cap and “279” on body, which are supplied as follows: Bottles of 100 NDC 43975-279-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsules 20 mg are hard gelatin capsules, pink opaque cap and body, printed “AMG” on cap and “280” on body, which are supplied as follows: Bottles of 100 NDC 43975-280-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsules 25 mg are hard gelatin capsules, pink opaque cap and white opaque body, printed “AMG” on cap and “281” on body, which are supplied as follows: Bottles of 100 NDC 43975-281-10 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsules 30 mg are hard gelatin capsules, pink opaque cap and clear body, printed “AMG” on cap and “282” on body, which are supplied as follows: Bottles of 100 NDC 43975-282-10 Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20°C to 25°C (68°F to 77°F). [see USP CONTROLLED ROOM TEMPERATURE].
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