isosorbide mononitrate 120 mg

INDICATIONS AND USAGE Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

lannett company, inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] methaemoglobinaemia` `[4] nausea` `[5] hyperthyroidism` `[6] foetal exposure during pregnancy` `[7] pyrexia` `[8] dyspnoea` `[9] exposure during pregnancy` `[10] fatigue`

3 years ago

OVAL WHITE KU129

HOW SUPPLIED Isosorbide Mononitrate Extended-Release Tablets, USP 30 mg are white, capsule-shaped tablets scored on one side and engraved "KU 128" on the unscored side. They are supplied as follows: Bottles of 90 NDC 62175-128-46 Bottles of 100 NDC 62175-128-37 Bottles of 500 NDC 62175-128-41 Bottles of 1000 NDC 62175-128-43 Isosorbide Mononitrate Extended-Release Tablets, USP 60 mg are white, capsule-shaped tablets scored on one side and engraved "KU 119" on the unscored side. They are supplied as follows: Bottles of 90 NDC 62175-119-46 Bottles of 100 NDC 62175-119-37 Bottles of 500 NDC 62175-119-41 Bottles of 1000 NDC 62175-119-43 Isosorbide Mononitrate Extended-Release Tablets, USP 120 mg are white, capsule-shaped tablets engraved "KU 129" on one side. They are supplied as follows: Bottles of 100 NDC 62175-129-37 Bottles of 1000 NDC 62175-129-43 Store at 20°-30°C (68°-86°F) [See USP]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIA71195F Rev. 02/19

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isosorbide mononitrate 120 mg

FDA Reported Adverse Reactions [1] drug ineffective [2] off label use [3] methaemoglobinaemia [4] nausea [5] hyperthyroidism [6] foetal exposure during pregnancy [7] pyrexia [8] dyspnoea [9] exposure during pregnancy [10] fatigue

OVAL WHITE KU129

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] methaemoglobinaemia` `[4] nausea` `[5] hyperthyroidism` `[6] foetal exposure during pregnancy` `[7] pyrexia` `[8] dyspnoea` `[9] exposure during pregnancy` `[10] fatigue`