modafinil tablet
1 INDICATIONS AND USAGE Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil 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 and during treatment with modafinil tablets for excessive sleepiness. Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). (1) Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
alembic pharmaceuticals limited
OVAL WHITE L234
L234 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
MODAFINIL Tablets USP 100 mg: white to off-white color, round shape, biconvex, uncoated tablets with ‘L233’ debossed on one side and plain on other side. NDC 46708-385-30 bottle of 30 tablets NDC 46708-385-60 bottle of 60 tablets NDC 46708-385-90 bottle of 90 tablets NDC 46708-385-91 bottle of 1000 tablets NDC 46708-385-10 100 (10 x 10) unit dose blisters tablets 200 mg: white to off-white color, round shape, biconvex, uncoated tablets with ‘L234’ debossed on one side and breakline on other side. NDC 46708-386-30 bottle of 30 tablets NDC 46708-386-60 bottle of 60 tablets NDC 46708-386-90 bottle of 90 tablets NDC 46708-386-91 bottle of 1000 tablets NDC 46708-386-10 100 (10 x 10) unit dose blisters tablets 16.2 Storage Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]
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