modafinil 200 MG Oral Tablet
1 INDICATIONS AND USAGE Modafinil is 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 is 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 for excessive sleepiness. Modafinil is 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 is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
CIMA LABS INC.
OVAL WHITE PROVIGIL 200 MG
PROVIGIL 200 MG OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
MODAFINIL tablets are available as follows: 100 mg: Each capsule-shaped, white to off white tablet is debossed with "PROVIGIL" on one side and "100 MG" on the other. NDC 55253-801-30 – Bottles of 30 NDC 55253-801-90 – Bottles of 90 200 mg: Each capsule-shaped, white to off white, scored tablet is debossed with "PROVIGIL" on one side and "200 MG" on the other. NDC 55253-802-30 – Bottles of 30 NDC 55253-802-90 – Bottles of 90 16.2 Storage Store at 20 o ‑ 25 o C (68 o ‑ 77 o F).
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