focalin xr 20 mg 24 hr extended release capsule

1 INDICATIONS AND USAGE Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Focalin XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).

novartis pharmaceuticals corporation

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

5 years ago

CAPSULE WHITE NVR D20

16 HOW SUPPLIED/STORAGE AND HANDLING Focalin XR (

DEXMETHYLPHENIDATE HYDROCHLORIDE) extended-release capsules are available as follows: • 5 mg capsules (NDC 0078-0430-05) light-blue, (imprinted “NVR D5”) supplied in bottles of 100 • 10 mg capsules (NDC 0078-0431-05) light caramel (imprinted “NVR D10”) supplied in bottles of 100 • 15 mg capsules (NDC 0078-0493-05) green (imprinted “NVR D15”) supplied in bottles of 100 • 20 mg capsules (NDC 0078-0432-05) white (imprinted “NVR D20”) supplied in bottles of 100 • 25 mg capsules (NDC 0078-0608-05) light-blue and white (imprinted “NVR D25”) supplied in bottles of 100 • 30 mg capsules (NDC 0078-0433-05) light caramel and white (imprinted “NVR D30”) supplied in bottles of 100 • 35 mg capsules (NDC 0078-0609-05) light-blue and light caramel (imprinted “NVR D35”) supplied in bottles of 100 • 40 mg capsules (NDC 0078-0434-05) green and white (imprinted “NVR D40”) supplied in bottles of 100 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).

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Novartis Pharmaceuticals Corporation

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