doxepin hydrochloride tablet
1 INDICATIONS AND USAGE Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. ( 1 , 14 )
mylan pharmaceuticals inc.
ROUND BLUE M D13
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Doxepin Tablets are available containing 3.39 mg or 6.78 mg of doxepin hydrochloride, USP equivalent to 3 mg or 6 mg of doxepin, respectively. The 3 mg tablets are light blue, round, unscored tablets debossed with M on one side of the tablet and DI3 on the other side. They are available as follows: NDC 0378-5390-93 bottles of 30 tablets NDC 0378-5390-01 bottles of 100 tablets NDC 0378-5390-05 bottles of 500 tablets The 6 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and DI6 on the other side. They are available as follows: NDC 0378-5391-93 bottles of 30 tablets NDC 0378-5391-01 bottles of 100 tablets NDC 0378-5391-05 bottles of 500 tablets 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. 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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