Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

Inclusion Criteria:

- at least 12 years of age

- use of at least 5 doses per month of over-the-counter pain relievers over the past 3
months

- provide written informed consent (subjects 12-<18 years of age provide a written
assent and parent/guardian will provide written informed consent)

- capable of and willing to swallow the study medication

Exclusion Criteria:

- participated in other research studies in the last 6 months

- they or someone else in their household work for a pharmaceutical company, is a
relative of study site personnel involved with the study, or an immediate family
member is already enrolled in the study

- have a history of known allergies to ibuprofen, aspirin, or other NSAIDs

- have a history of heart surgery in the last 60 days or planned heart surgery in the
next 60 days

- female subjects are pregnant or breast feeding