zileuton tablet multilayer extended release

1 INDICATIONS AND USAGE Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with zileuton extended-release tablets can be continued during acute exacerbations of asthma. Zileuton extended-release tablets are leukotriene synthesis inhibitors indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ( 1 ) Do not use zileuton extended-release tablets to treat an acute asthma attack. ( 1 )

dash pharmaceutical llc

FDA Reported Adverse Reactions
`[1] nausea` `[2] fatigue` `[3] off label use` `[4] drug ineffective` `[5] pain` `[6] diarrhoea` `[7] headache` `[8] dyspnoea` `[9] vomiting` `[10] pyrexia`

4 years ago

OVAL WHITE D130

16 HOW SUPPLIED/STORAGE AND HANDLING Zileuton extended-release white to off-white color oblong shaped film coated tablets are debossed with D130 on one side and plain on another side; they are available in bottles of 120 tablets with child-resistant closure. (NDC 69339-130-12). Store between 20 and 25°C (68-77ºF); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light.

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zileuton tablet multilayer extended release

FDA Reported Adverse Reactions [1] nausea [2] fatigue [3] off label use [4] drug ineffective [5] pain [6] diarrhoea [7] headache [8] dyspnoea [9] vomiting [10] pyrexia

OVAL WHITE D130

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FDA Reported Adverse Reactions
`[1] nausea` `[2] fatigue` `[3] off label use` `[4] drug ineffective` `[5] pain` `[6] diarrhoea` `[7] headache` `[8] dyspnoea` `[9] vomiting` `[10] pyrexia`