Diazepam 10 MG Oral Tablet
INDICATIONS AND USAGE Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
STAT Rx USA LLC
ROUND GREEN MYLAN 477
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HOW SUPPLIED Diazepam Tablets, USP are available containing 5 mg or 10 mg of Diazepam, USP. The 5 mg tablets are orange, round, scored tablets debossed with MYLAN over 345 on one side and the other side being scored. They are available as follows: NDC 42549-603-92 bottles of 2 tablets NDC 42549-603-20 bottles of 20 tablets NDC 42549-603-30 bottles of 30 tablets NDC 42549-603-60 bottles of 60 tablets NDC 42549-603-90 bottles of 90 tablets The 10 mg tablets are green, round, scored tablets debossed with MYLAN over 477 on one side and the other side being scored. They are available as follows: NDC 42549-554-92 bottles of 2 tablets NDC 42549-554-20 bottles of 20 tablets NDC 42549-554-30 bottles of 30 tablets NDC 42549-554-60 bottles of 60 tablets NDC 42549-554-90 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED OCTOBER 2008 DPM:R13 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA 30501
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