armodafinil 50 MG Oral Tablet
1 INDICATIONS AND USAGE Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). ( 1 ) Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
Mylan Pharmaceuticals Inc.
ROUND WHITE M A31
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
ARMODAFINIL Tablets are available containing 50 mg, 150 mg or 250 mg of
ARMODAFINIL. The 50 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and A31 on the other side. They are available as follows: NDC 0378-3431-93 bottles of 30 tablets The 150 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and A32 on the other side. They are available as follows: NDC 0378-3432-93 bottles of 30 tablets The 250 mg tablets are white to off-white, capsule shaped, unscored tablets debossed with M on one side of the tablet and A33 on the other side. They are available as follows: NDC 0378-3433-93 bottles of 30 tablets 16.2 Storage 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.
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