Patent ID: 8653066

Claim:
A bi-layer tablet comprising (a) an immediate-release layer that comprises promethazine or a pharmaceutically acceptable salt thereof; and (b) a controlled-release layer that comprises an opioid analgesic agent and a non-opioid analgesic agent, wherein the non-opioid analgesic agent is acetaminophen or a pharmaceutically acceptable salt thereof, wherein the opioid analgesic agent is hydrocodone, oxycodone, or a pharmaceutically acceptable salt thereof, wherein about 90% of the promethazine or a pharmaceutically acceptable salt thereof is released in about 1 minute to about 20 minutes following administration and about 100% of the promethazine or a pharmaceutically acceptable salt thereof is released within about 1 hour following administration, and wherein the hydrocodone, oxycodone, or a pharmaceutically acceptable salt thereof, is released within about 20 minutes to about 180 minutes following administration.