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.
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 â€˜376â€™ on one side and â€˜Sâ€™ above â€˜2.5â€™ 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 â€˜378â€™ on one side and â€˜Sâ€™ above â€˜5â€™ 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 â€˜379â€™ on one side and â€˜Sâ€™ above â€˜10â€™ 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 20Â°C to 25Â°C (68Â°F to 77Â°F), with excursions permitted between 15Â°C and 30Â°C (59Â°F to 86Â°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. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired
DEXMETHYLPHENIDATE HYDROCHLORIDE tablets by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix
DEXMETHYLPHENIDATE HYDROCHLORIDE tablets with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and discard
DEXMETHYLPHENIDATE HYDROCHLORIDE tablets in the household trash.
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