methylphenidate hydrochloride tablet extended release
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults Narcolepsy Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy
granules pharmaceuticals inc.
ROUND WHITE FM5
FM5 ROUND WHITE
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methylphenidate hydrochloride tablet extended release
granules pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, USP are available as follows: 10 mg: white to off white, round shaped, uncoated, tablets debossed with “FM4” on one side and “plain” on other side. Bottles of 100 tablets NDC 70010-042-01 Bottles of 30 tablets NDC 70010-042-03 20 mg: white to off white, round shaped, uncoated, tablets debossed with “FM5” on one side and “plain” on other side. Bottles of 100 tablets NDC 70010-043-01 Bottles of 30 tablets NDC 70010-043-03 NOTE:
METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, USP are color-additive free. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired
METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, USP by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix
METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, USP with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard
METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, USP in the household trash.
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