24 HR venlafaxine 150 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Venlafaxine hydrochloride extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) 1.1 Major Depressive Disorder Venlafaxine hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [ see Clinical Studies ( 14.1 ) ]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
Sun Pharma Global Inc.
OVAL 758
758 OVAL
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16 HOW SUPPLIED/STORAGE AND HANDLING Venlafaxine hydrochloride extended-release tablets are available as follows: 37.5 mg, round, pink and white colored biconvex bilayer coated tablet imprinted with "760" with black ink on one side and plain on other side. Bottles of 30’s with Child Resistant Cap………..…....NDC 41616- 760 -83 Bottles of 90’s with Child Resistant Cap……………..NDC 41616-760-81 Bottles of 100’s with Child Resistant Cap…………....NDC 41616-760-88 Bottles of 100’s with Non Child Resistant Cap……....NDC 41616-760-08 Bottles of 1000’s with Non Child Resistant Cap……..NDC 41616-760-18 75 mg, round, pink and white colored biconvex bilayer coated tablet imprinted with "759" with black ink on one side and plain on other side. Bottles of 30's with Child Resistant Cap………….....NDC 41616-759-83 Bottles of 90’s with Child Resistant Cap…………….NDC 41616-759-81 Bottles of 100's with Child Resistant Cap...................NDC 41616-759-88 Bottles of 100's with Non Child Resistant Cap….......NDC 41616-759-08 Bottles of 1000's with Non Child Resistant Cap.........NDC 41616-759-18 150 mg, oval, pink and white colored biconvex bilayer coated tablet imprinted with "758" with black ink on one side and plain on other side. Bottles of 30's with Child Resistant Cap…………......NDC 41616-758-83 Bottles of 90's with Child Resistant Cap…………......NDC 41616-758-81 Bottles of 100's with Child Resistant Cap....................NDC 41616-758-88 Bottles of 100's with Non Child Resistant Cap............NDC 41616-758-08 Bottles of 1000's with Non Child Resistant Cap…......NDC 41616-758-18 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from moisture and humidity.
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