quillichew er methylphenidate hydrochloride tablet chewable extended release
1 INDICATIONS AND USAGE QuilliChew ER is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 ) ]. QuilliChew ER is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). ( 1 )
nextwave pharmaceuticals, inc
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied QuilliChew ER is supplied as extended-release chewable tablets in 20 mg, 30 mg and 40 mg strengths. The 20 mg strength extended-release chewable tablet is available as a speckled, off-white, capsule-shaped coated tablet, debossed with "NP 12" on one side and functionally scored on the other side. The 30 mg strength extended-release chewable tablet is available as a speckled, light pink color, capsule-shaped coated tablet, debossed with "NP 13" on one side and functionally scored on the other side. The 40 mg strength extended-release chewable tablet is available as a speckled, dark pink to peach color, capsule-shaped coated tablet, debossed with "NP 14" on one side and plain on the other side (not scored). The product is supplied in bottles of 100. QuilliChew ER extended-release chewable tablets Package Configuration Tablet Strength (mg) NDC Print Bottles of 100 20 mg NDC-24478-074-01 NP 12 Bottles of 100 30 mg NDC-24478-075-01 NP 13 Bottles of 100 40 mg NDC-24478-076-01 NP 14 16.2 Storage and Handling Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.]
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