24 HR Methylphenidate Hydrochloride 54 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Methylphenidate hydrochloride (HCl) extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65 [see Clinical Studies (14) ] . Methylphenidate HCl extended-release tablets are a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65. (1)
Amneal Pharmaceuticals LLC
ROUND RED 54
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16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate HCl extended-release tablets, USP, 18 mg, are supplied as yellow, round, film-coated biconvex tablets, debossed “18” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-231-03 Bottles of 90: NDC 65162-231-09 Methylphenidate HCl extended-release tablets, USP, 27 mg, are supplied as gray, round, film-coated biconvex tablets, debossed “27” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-233-03 Bottles of 90: NDC 65162-233-09 Methylphenidate HCl extended-release tablets, USP, 36 mg, are supplied as white, round, film-coated biconvex tablets, debossed “36” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-235-03 Bottles of 90: NDC 65162-235-09 Methylphenidate HCl extended-release tablets, USP, 54 mg, are supplied as red, round, film-coated biconvex tablets, debossed “54” on one side and plain on the other side. They are supplied as follows: Bottles of 30: NDC 65162-237-03 Bottles of 90: NDC 65162-237-09 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from humidity.
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