dexmethylphenidate hydrochloride 5 mg
1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)] . Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (1).
Ascent Pharmaceuticals, Inc.
CAPSULE BROWN M5 AC
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16 HOW SUPPLIED/STORAGE AND HANDLING
DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules are available containing 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of
DEXMETHYLPHENIDATE HYDROCHLORIDE. 5 mg extended-release capsules are hard gelatin capsule size “2†light brown cap and white opaque body, imprinted with “M5†on cap and “AC†on body in black ink filled with white to off white spherical pellets. They are available as follows: NDC 43602-327-30 bottles of 30 capsules NDC 43602-327-05 bottles of 500 capsules 10 mg extended-release capsules are hard gelatin capsule size “2†white opaque cap and white opaque body, imprinted with “M10†on cap and “AC†on body in black ink filled with white to off white spherical pellets. They are available as follows: NDC 43602-328-30 bottles of 30 capsules NDC 43602-328-05 bottles of 500 capsules 15 mg extended-release capsules are hard gelatin capsule size “1†yellow opaque cap and white opaque body, imprinted with “M15†on cap and “AC†on body in black ink filled with white to off white spherical pellets. They are available as follows: NDC 43602-329-30 bottles of 30 capsules NDC 43602-329-05 bottles of 500 capsules 20 mg extended-release capsules are hard gelatin capsule size “1†light brown cap and white opaque body, imprinted with “M20†on cap and “AC†on body in black ink filled with white to off white spherical pellets. They are available as follows: NDC 43602-330-30 bottles of 30 capsules NDC 43602-330-05 bottles of 500 capsules 25 mg extended-release capsules are hard gelatin capsule size “0†yellow opaque cap and white opaque body, imprinted with “M25†on cap and “AC†on body in black ink filled with white to off white spherical pellets. They are available as follows: NDC 43602-331-30 bottles of 30 capsules NDC 43602-331-05 bottles of 500 capsules 30 mg extended-release capsules are hard gelatin capsule size “00†white opaque cap and white opaque body, imprinted with “M30†on cap and “AC†on body in black ink filled with white to off white spherical pellets. They are available as follows: NDC 43602-332-30 bottles of 30 capsules NDC 43602-332-05 bottles of 500 capsules 35 mg extended-release capsules are hard gelatin capsule size “00†light yellow opaque cap and light yellow opaque body, imprinted with “M35†on cap and “AC†on body in red ink filled with white to off white spherical pellets. They are available as follows: NDC 43602-333-30 bottles of 30 capsules NDC 43602-333-05 bottles of 500 capsules 40 mg extended-release capsules are hard gelatin capsule size “00†yellow opaque cap and white opaque body, imprinted with “M40†on cap and “AC†on body in black ink filled with white to off white spherical pellets. They are available as follows: NDC 43602-334-30 bottles of 30 capsules NDC 43602-334-05 bottles of 500 capsules 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]. Dispense in tight container (USP). Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired
DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules by a medicine take-back 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 extended-release capsules with an undesirable, non-toxic 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 extended-release capsules in the household trash.
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