- Males and females at least 18 years to 65 years of age
- A diagnosis of an episodic tension-type headache, as defined by the International
Headache Society
- A history of episodic tension-type headache with the following characteristics: 4
headache episodes per month for the last 6 months of moderately severe intensity;
headache generally lasts more than 3 hours if left untreated; adequate headache relief
is generally obtained with over-the-counter (OTC) doses of OTC analgesics
- Pregnancy or breast-feeding
- Alcohol or substance abuse
- Any serious medical or psychiatric disorder
- History of stomach ulcers, stomach bleed, or other bleeding disorders