dextroamphetamine saccharate amphetamine aspartate monohydrate dextroamphetamine sulfate amphetamine sulfate capsule extended release

1 INDICATIONS AND USAGE Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, 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, 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.

actavis pharma, inc.

FDA Reported Adverse Reactions
`[1] fatigue` `[2] drug ineffective` `[3] dyspnoea` `[4] nausea` `[5] diarrhoea` `[6] pain` `[7] headache` `[8] dizziness` `[9] off label use` `[10] vomiting`

6 years ago

CAPSULE BLUE R3060

16 HOW SUPPLIED/STORAGE AND HANDLING

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE extended-release capsules are available as follows: 5 mg – Each #3 capsule with light blue opaque cap and orange opaque body printed with and 3062 on the cap and body in black ink contains 1.25 mg of dextroamphetamine saccharate, 1.25 mg of amphetamine aspartate monohydrate, 1.25 mg of dextroamphetamine sulfate USP, and 1.25 mg of amphetamine sulfate USP. capsules are supplied in bottles of 100 (NDC 0228-3062-11) with a child-resistant closure. 10 mg – Each #3 capsule with light blue opaque cap and ivory opaque body printed with and 3059 on the cap and body in black ink contains 2.5 mg of dextroamphetamine saccharate, 2.5 mg of amphetamine aspartate monohydrate, 2.5 mg of dextroamphetamine sulfate USP, and 2.5 mg of amphetamine sulfate USP. capsules are supplied in bottles of 100 (NDC 0228-3059-11) with a child-resistant closure. 15 mg – Each #2 capsule with ivory opaque cap and orange opaque body printed with and 3063 on the cap and body in black ink contains 3.75 mg of dextroamphetamine saccharate, 3.75 mg of amphetamine aspartate monohydrate, 3.75 mg of dextroamphetamine sulfate USP, and 3.75 mg of amphetamine sulfate USP. capsules are supplied in bottles of 100 (NDC 0228-3063-11) with a child-resistant closure. 20 mg – Each #2 capsule with light blue opaque cap and light blue opaque body printed with and 3060 on the cap and body in black ink contains 5.0 mg of dextroamphetamine saccharate, 5.0 mg of amphetamine aspartate monohydrate, 5.0 mg of dextroamphetamine sulfate USP, and 5.0 mg of amphetamine sulfate USP. capsules are supplied in bottles of 100 (NDC 0228-3060-11) with a child-resistant closure. 25 mg – Each #1 capsule with ivory opaque cap and ivory opaque body printed with and 3064 on the cap and body in black ink contains 6.25 mg of dextroamphetamine saccharate, 6.25 mg of amphetamine aspartate monohydrate, 6.25 mg of dextroamphetamine sulfate USP, and 6.25 mg of amphetamine sulfate USP. capsules are supplied in bottles of 100 (NDC 0228-3064-11) with a child-resistant closure. 30 mg – Each #1 capsule with orange opaque cap and orange opaque body printed with and 3061 on the cap and body in black ink contains 7.5 mg of dextroamphetamine saccharate, 7.5 mg of amphetamine aspartate monohydrate, 7.5 mg of dextroamphetamine sulfate USP, and 7.5 mg of amphetamine sulfate USP. capsules are supplied in bottles of 100 (NDC 0228-3061-11) with a child-resistant closure. Dispense in a tight, light-resistant container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. 6df967f2-figure-08 6df967f2-figure-09 6df967f2-figure-10 6df967f2-figure-11 6df967f2-figure-12 6df967f2-figure-13

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