armodafinil 250 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.
aurobindo pharma limited
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
ARMODAFINIL Tablets, 50 mg are white to off-white, round shaped uncoated tablets debossed with ‘K’ on one side and ‘58’ on the other side. Bottles of 30 NDC 65862-805-30 Bottles of 60 NDC 65862-805-60 Bottles of 500 NDC 65862-805-05
ARMODAFINIL Tablets, 150 mg are white to off-white, oval shaped uncoated tablets debossed with ‘K’ on one side and ‘59’ on the other side. Bottles of 30 NDC 65862-806-30 Bottles of 60 NDC 65862-806-60 Bottles of 500 NDC 65862-806-05
ARMODAFINIL Tablets, 200 mg are white to off-white rounded, rectangular uncoated tablets debossed with ‘10’ on one side and ‘N’ on the other side. Bottles of 30 NDC 65862-998-30
ARMODAFINIL Tablets, 250 mg are white to off-white, oval shaped uncoated tablets debossed with ‘K’ on one side and ‘60’ on the other side. Bottles of 30 NDC 65862-807-30 Bottles of 60 NDC 65862-807-60 Bottles of 500 NDC 65862-807-05 16.2 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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