Warfarin Sodium 3 MG Oral Tablet

1 INDICATIONS AND USAGE Warfarin sodium tablets are indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. Warfarin sodium tablets are vitamin K antagonist indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism. (1) Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. (1) Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction. (1) Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. (1)

Amneal Pharmaceuticals LLC

FDA Reported Adverse Reactions
`[1] nausea` `[2] fatigue` `[3] diarrhoea` `[4] dyspnoea` `[5] drug ineffective` `[6] headache` `[7] dizziness` `[8] pain` `[9] vomiting` `[10] chronic kidney disease`

4 years ago

OVAL BROWN 764 3 AN

16 HOW SUPPLIED/STORAGE AND HANDLING Tablets

WARFARIN Sodium Tablets USP, 1 mg are supplied as pink to light pink, oval shaped uncoated scored tablets with debossing ‘761’ and ‘1’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-761-10 Bottle of 500 Tablets: NDC 65162-761-50 Bottle of 1000 Tablets: NDC 65162-761-11

WARFARIN Sodium Tablets USP, 2 mg are supplied as Lavender to light Lavender, oval shaped uncoated scored tablets with debossing ‘762’ and ‘2’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-762-10 Bottle of 500 Tablets: NDC 65162-762-50 Bottle of 1000 Tablets: NDC 65162-762-11

WARFARIN Sodium Tablets USP, 2½ mg are supplied as green to light green, oval shaped uncoated scored tablets with debossing ‘763’ and ‘2½’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-763-10 Bottle of 500 Tablets: NDC 65162-763-50 Bottle of 1000 Tablets: NDC 65162-763-11

WARFARIN Sodium Tablets USP, 3 mg are supplied as tan to light tan, oval shaped uncoated scored tablets with debossing ‘764’ and ‘3’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-764-10 Bottle of 500 Tablets: NDC 65162-764-50 Bottle of 1000 Tablets: NDC 65162-764-11

WARFARIN Sodium Tablets USP, 4 mg are supplied as blue to light blue, oval shaped uncoated scored tablets with debossing ‘765’ and ‘4’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-765-10 Bottle of 500 Tablets: NDC 65162-765-50 Bottle of 1000 Tablets: NDC 65162-765-11

WARFARIN Sodium Tablets USP, 5 mg are supplied as peach to light peach, oval shaped uncoated scored tablets with debossing ‘766’ and ‘5’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-766-10 Bottle of 500 Tablets: NDC 65162-766-50 Bottle of 1000 Tablets: NDC 65162-766-11

WARFARIN Sodium Tablets USP, 6 mg are supplied as teal to light teal, oval shaped uncoated scored tablets with debossing ‘767’ and ‘6’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-767-10 Bottle of 500 Tablets: NDC 65162-767-50 Bottle of 1000 Tablets: NDC 65162-767-11

WARFARIN Sodium Tablets USP, 7½ mg are supplied as yellow to light yellow, oval shaped uncoated scored tablets with debossing ‘768’ and ‘7½’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-768-10 Bottle of 500 Tablets: NDC 65162-768-50 Bottle of 1000 Tablets: NDC 65162-768-11

WARFARIN Sodium Tablets USP, 10 mg are supplied as white to off white, oval shaped uncoated scored tablets with debossing ‘769’ and ‘10’ on either side of the breakline on one side and ‘AN’ on the other side. They are available as follows: Bottle of 100 Tablets: NDC 65162-769-10 Bottle of 500 Tablets: NDC 65162-769-50 Bottle of 1000 Tablets: NDC 65162-769-11 Protect from light and moisture. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Special Handling Procedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published [see References (15) ]. Pharmacy and clinical personnel who are pregnant should avoid exposure to crushed or broken tablets [see Use in Specific Populations (8.1) ].

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