Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain

This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with
diclofenac potassium oral solution, based on weight, every 6 hours as needed for the
treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected
through 6 hours after the first dose. Safety data will be collected throughout the study.

Inclusion Criteria:

- Male and female subjects between 2-12 years of age.

- Subjects must be post-op, having mild or moderate acute pain.

Other inclusions apply.

Exclusion Criteria:

- Subject has a known history of allergic reaction, hypersensitivity to diclofenac,
aspirin, acetaminophen, or reaction to the non-active ingredients of the study
medication.

- Subject has been taking analgesics for 48-72 hours prior to Screening.

- Subject has a history of any GI event greater than 6 months before Screening.

- Subject is currently receiving any medication that is contraindicated for use
concomitantly with diclofenac or acetaminophen.

- Subject is requiring treatment for pre-existing hypertension.

Other exclusions apply.