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24 HR dexmethylphenidate hydrochloride 25 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 ).

teva pharmaceuticals usa, inc.


3 years ago CAPSULE BLUE Teva 5045 24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule

CAPSULE BLUE Teva 5045

16 HOW SUPPLIED/STORAGE AND HANDLING

DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules are available as follows: 5 mg: Two-piece hard-gelatin capsule with aqua-blue-opaque cap and aqua-blue-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5550” on body in bottles of 100 (NDC 0093-5550-01). 10 mg: Two-piece hard-gelatin capsule with ivory-opaque cap and ivory-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5551” on body in bottles of 100 (NDC 0093-5551-01). 15 mg: Two-piece hard-gelatin capsule with blue-green-opaque cap and blue-green-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5552” on body in bottles of 100 (NDC 0093-5552-01). 20 mg: Two-piece hard-gelatin capsule with white-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5553” on body in bottles of 100 (NDC 0093-5553-01). 25 mg: Two-piece hard-gelatin capsule with aqua blue opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5045” on body in bottles of 100 (NDC 0093-5045-01). 30 mg: Two-piece hard-gelatin capsule with ivory-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5554” on body in bottles of 100 (NDC 0093-5554-01). 35 mg: Two-piece hard-gelatin capsule with aqua blue opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5046” on body in bottles of 100 (NDC 0093-5046-01). 40 mg: Two-piece hard-gelatin capsule with blue-green cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5562” on body in bottles of 100 (NDC 0093-5562-01). 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. 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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