Trazodone Hydrochloride 100 MG Oral Tablet
1 INDICATIONS AND USAGE Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ).
Accord Healthcare, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
TRAZODONE HYDROCHLORIDE tablets, USP 50 mg having functional scoring are available for oral administration as white to off white, round, biconvex, uncoated tablets Engraved βITβ bisect β50β on one side and plain on the other side. Bottles of 100 with a child-resistant closure (NDC 16729-299-01) Bottles of 500 (NDC 16729-299-16) Bottles of 1000 (NDC 16729-299-17) Unit Dose Blister Packages of 100 (10 x 10 unit dose) (NDC 16729-299-43)
TRAZODONE HYDROCHLORIDE tablets, USP 100 mg having functional scoring are available for oral administration as white to off white, round, biconvex, uncoated tablets Engraved βITβ bisect β100β on one side and plain on the other side. Bottles of 100 with a child-resistant closure (NDC 16729-300-01) Bottles of 500 (NDC 16729-300-16) Bottles of 1000 (NDC 16729-300-17) Unit Dose Blister Packages of 100 (10 x 10 unit dose) (NDC 16729-300-43)
TRAZODONE HYDROCHLORIDE tablets, USP 150 mg having functional scorings are available for oral administration as white to off white, oval, flat faced bevelled edge uncoated tablets with full bisect and two partial trisects engraved βITβ and β150β on one side and two trisect engraved β50 50 50β on each part with middle β50β perpendicular to the other on other side. Bottles of 100 with a child-resistant closure (NDC 16729-301-01) Bottles of 500 (NDC 16729-301-16) Bottles of 1000 (NDC 16729-301-17) Directions for using the correct score when breaking the tablet, please refer to the following: -For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 75 mg, break the score down the middle of the tablet (one-half of a tablet). -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 150 mg, use the entire tablet.
TRAZODONE HYDROCHLORIDE tablets, USP 300 mg having functional scorings are available for oral administration as white to off white, oval, flat faced bevelled edge uncoated tablets with full bisect and two partial trisects engraved βITβ and β300β on one side and two trisect engraved β100 100 100β on each part with middle β100β perpendicular to the other on other side. Bottles of 100 with a child-resistant closure (NDC 16729-302-01) Bottles of 500 (NDC 16729-302-16) Bottles of 1000 (NDC 16729-302-17) Directions for using the correct score when breaking the tablet, please refer to the following: -For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 300 mg, use the entire tablet. Store at 20Β°C to 25Β°C (68Β°F to 77Β°F); excursions permitted to 15Β°C to 30Β°C (59Β°F to 86Β°F) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container. 50mg-score 75mg-score 100mg-score 150mg-tablet 100mg-break 150mg-break 200mg-break 300mg-break
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