MECLOFENAMATE SUMMARY
MECLOFENAMATE SODIUM CAPSULES, USP 50 mg and 100 mg
Meclofenamate sodium is N-(2,6-dichloro-m-tolyl) anthranilic acid, sodium salt, monohydrate. It is an anti-inflammatory drug for oral administration.
Meclofenamate sodium is indicated for the relief of mild to moderate pain.
Meclofenamate sodium is also indicated for the treatment of primary dysmenorrhea and for the treatment of idiopathic heavy menstrual blood loss (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Meclofenamate sodium is also indicated for relief of the signs and symptoms of acute and chronic rheumatoid arthritis and osteoarthritis. As with all non-steroidal anti-inflammatory drugs, selection of meclofenamate sodium requires a careful assessment of the benefit/risk ratio (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS).
Meclofenamate sodium is not recommended in children because adequate studies to demonstrate safety and efficacy have not been carried out.
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