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24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule

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 ).

Mylan Pharmaceuticals Inc.


4 years ago CAPSULE BROWN MYLAN DE 30 24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule

CAPSULE BROWN MYLAN DE 30

16 HOW SUPPLIED/STORAGE AND HANDLING Dexmethylphenidate Hydrochloride Extended-Release capsules are available containing 5 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg of dexmethylphenidate hydrochloride. The 5 mg capsules are hard-shell gelatin capsules with a dark blue opaque cap and dark blue opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 5 in white ink on cap and body. They are available as follows: NDC 0378-4080-01 bottles of 100 capsules The 10 mg capsules are hard-shell gelatin capsules with a light brown opaque cap and light brown opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 10 in black ink on cap and body. They are available as follows: NDC 0378-4081-01 bottles of 100 capsules The 15 mg capsules are hard-shell gelatin capsules with a gray opaque cap and gray opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 15 in black ink on cap and body. They are available as follows: NDC 0378-4082-01 bottles of 100 capsules The 20 mg capsules are hard-shell gelatin capsules with a white opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 20 in black ink on cap and body. They are available as follows: NDC 0378-4083-01 bottles of 100 capsules The 30 mg capsules are hard-shell gelatin capsules with a light brown opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 30 in black ink on cap and body. They are available as follows: NDC 0378-4084-01 bottles of 100 capsules The 40 mg capsules are hard-shell gelatin capsules with a gray opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 40 in black ink on cap and body. They are available as follows: NDC 0378-4085-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. 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 takeback program or 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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