Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

This is a single-dose, randomized, double-blind, placebo- and active- controlled,
parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test
ACM 1000 mg compared with two commercial products over a four-hour period after third-molar
extractions. Subjects will undergo dental extraction of three or four third molars.

Inclusion Criteria:

1. 17 to 50 years old

2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)

3. Dental extraction of three or four third molars

4. Meets post-surgical pain criteria

5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria:

1. Currently pregnant or planning to be pregnant or nursing a baby

2. Known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs)
including aspirin, as well as hydrocodone or other opioids

3. Inability to swallow whole large tablets or capsules

4. Have other conditions that the investigator feels may impact subject's safety and/or
the integrity of the study

5. Use of pain medications 5 or more times per week

6. Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the
last 5 years

7. History of endoscopically documented peptic ulcer disease or bleeding disorder in the
last 2 years

8. Have a positive urine drug screen