dexmethylphenidate hydrochloride tablet
1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).
sun pharmaceutical industries, inc.
ROUND YELLOW S 5 378
S 5 378 ROUND YELLOW
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dexmethylphenidate hydrochloride 5 mg
sun pharmaceutical industries, inc.
dexmethylphenidate hydrochloride tablet
sun pharmaceutical industries, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
DEXMETHYLPHENIDATE HYDROCHLORIDE tablets are available as follows: 2.5 mg: Light blue colored, round, biconvex, beveled edge, uncoated, tablets debossed ‘376’ on one side and ‘S’ above ‘2.5’ on the other side. NDC 57664-376-83 Bottles of 30 CRC NDC 57664-376-88 Bottles of 100 CRC NDC 57664-376-08 Bottles of 100 NDC 57664-376-13 Bottles of 500 NDC 57664-376-18 Bottles of 1,000 5 mg: Light yellow colored, round, biconvex, beveled edge, uncoated, tablets debossed ‘378’ on one side and ‘S’ above ‘5’ on the other side. NDC 57664-378-83 Bottles of 30 CRC NDC 57664-378-88 Bottles of 100 CRC NDC 57664-378-08 Bottles of 100 NDC 57664-378-13 Bottles of 500 NDC 57664-378-18 Bottles of 1,000 10 mg: white, round, biconvex, beveled edge, uncoated, tablets debossed ‘379’ on one side and ‘S’ above ‘10’ on the other side. NDC 57664-379-83 Bottles of 30 CRC NDC 57664-379-88 Bottles of 100 CRC NDC 57664-379-08 Bottles of 100 NDC 57664-379-13 Bottles of 500 NDC 57664-379-18 Bottles of 1,000 Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
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