Carefully consider the potential benefits and risks of PONSTEL and other treatment options before deciding to use PONSTEL. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

PONSTEL is indicated:

• For relief of mild to moderate pain in patients =14 years of age, when therapy will not exceed one week (7 days).
• For treatment of primary dysmenorrhea.

Carefully consider the potential benefits and risks of PONSTEL and other treatment options before deciding to use PONSTEL. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with PONSTEL, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of acute pain in adults and adolescents =14 years of age, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours as needed, usually not to exceed one week.⁴

For the treatment of primary dysmenorrhea, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours, given orally, starting with the onset of bleeding and associated symptoms. Clinical studies indicate that effective treatment can be initiated with the start of menses and should not be necessary for more than 2 to 3 days.⁵

Ponstel (mefenamic acid) is available as 250 mg blue-banded, ivory capsules, imprinted with "FHPC 400" and "PONSTEL®".

Bottles of 100...................NDC 59630-400-10

Storage

Store at 20- 25°C (68- 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

REFERENCES

4. Glazko AJ: Experimental observations of flufenamic, mefenamic, and meclofenamic acids. Part III. Metabolic disposition, in Fenamates in Medicine. A Symposium, London, 1966. Annals of Physical Medicine, Supplement, pp 23-36, 1967.

5. Data on file, First Horizon (Protocol 356).

Distributed by: Atlanta, GA 30328. Revised March 2007. FDA Rev date: 3/6/2008

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