dexmethylphenidate hydrochloride capsule extended release
1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )]. Dexmethylphenidate hydrochloride extended-release is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).
par pharmaceutical, inc.
CAPSULE YELLOW Par 333
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16 HOW SUPPLIED/STORAGE AND HANDLING
DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules are available as follows: 5 mg Extended-Release capsules (NDC 49884-048-01) light blue opaque body with a light blue opaque cap printed with “par” on capsule and 048 on body in black ink supplied in bottles of 100. 10 mg Extended-Release capsules (NDC 49884-049-01) beige opaque body with a beige opaque cap printed with “par” on capsule and 049 on body in black ink supplied in bottles of 100. 15 mg Extended-Release capsules (NDC 49884-090-01) spring green opaque body with a spring green opaque cap printed with “par” on capsule and 090 on body in black ink supplied in bottles of 100. 20 mg Extended-Release capsules (NDC 49884-248-01) white opaque body with a white opaque cap printed with “par” on capsule and 248 on body in black ink supplied in bottles of 100. 25 mg Extended-Release capsules (NDC 49884-333-01) white opaque body with a yellow transparent cap printed with “par” on capsule and 333 on body in black ink supplied in bottles of 100. 30 mg Extended-Release capsules (NDC 49884-539-01) white opaque body with a yellow transparent cap printed with “par” on capsule and 539 on body in black ink supplied in bottles of 100. 35 mg Extended-Release capsules (NDC 49884-339-01) white opaque body with a yellow transparent cap printed with “par” on capsule and 339 on body in black ink supplied in bottles of 100. 40 mg Extended-Release capsules (NDC 49884-546-01) white opaque body with a yellow transparent cap printed with “par” on capsule and 546 on body in black ink supplied in bottles of 100. Store
DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).
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