24 HR Amphetamine aspartate 1.25 MG Amphetamine Sulfate 1.25 MG Dextroamphetamine saccharate 1.25 MG Dextroamphetamine Sulfate 1.25 MG Extended Release Oral Capsule

1 INDICATIONS AND USAGE Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release Capsules, a CNS stimulant, are 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.

Amneal Pharmaceuticals of New York LLC

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

5 years ago

CAPSULE BROWN G451

16 HOW SUPPLIED/STORAGE AND HANDLING Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules (mixed salts of a single-entity amphetamine product), 5 mg are natural bodies and light turquoise blue opaque caps, imprinted with “G451” in black ink on cap. Appearance of contents: beige spherical particles. Bottles of 100.................................................................................................... NDC 0115-1486-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules (mixed salts of a single-entity amphetamine product), 10 mg are light turquoise blue bodies and light turquoise blue opaque caps, imprinted with “G452” in black ink on cap. Appearance of contents: beige spherical particles. Bottles of 100.................................................................................................... NDC 0115-1487-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules (mixed salts of a single-entity amphetamine product), 15 mg are light turquoise blue bodies and white opaque caps, imprinted with “G453” in black ink on cap. Appearance of contents: beige spherical particles. Bottles of 100.................................................................................................... NDC 0115-1488-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules (mixed salts of a single-entity amphetamine product), 20 mg are light brown bodies and light brown opaque caps, imprinted with “G454” in black ink on cap. Appearance of contents: beige spherical particles. Bottles of 100.................................................................................................... NDC 0115-1489-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules (mixed salts of a single-entity amphetamine product), 25 mg are light brown bodies and white opaque caps, imprinted with “G455” in black ink on cap. Appearance of contents: beige spherical particles. Bottles of 100.................................................................................................... NDC 0115-1490-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules (mixed salts of a single-entity amphetamine product), 30 mg are natural bodies and light brown opaque caps, imprinted with “G456” in black ink on cap. Appearance of contents: beige spherical particles. Bottles of 100.................................................................................................... NDC 0115-1491-01 Dispense in a tight, light-resistant container as defined in the USP. Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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