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Naproxen or its salts..

In preparations containing the equivalent of 200 mg of naproxen base* per oral dosage unit, when sold in products labelled with a recommended maximum daily dose equivalent to 400 mg of naproxen base, and in package sizes exceeding the equivalent of 6,000 mg of naproxen base.

[*220 mg naproxen sodium approximately equivalent to 200 mg naproxen base]

Approval Date:

Schedule: III