| Summary: | The efficacy and safety of a single dose of two Extra Strength BAYER Aspirin Caplets (each containing aspirin 500 mg) was compared with one TYLENOL with Codeine #3 Tablet (containing acetaminophen 300 mg plus codeine phosphate 30 mg) or placebo in the treatment of subjects with acute postsurgical dental pain. One hundred twenty subjects who dosed with Extra Strength BAYER Aspirin and 121 subjects who dosed with TYLENOL with Codeine were compared with 61 subjects who dosed with placebo in this double-blind, randomized, parallel group, placebo-controlled, single-dose clinical trial. Qualified subjects who experienced moderate to severe pain following surgical extraction of two or more third molars were randomly allocated to receive two Extra Strength BAYER Aspirin Caplets, one TYLENOL with Codeine #3 Tablet, or placebo. At 30 minutes, 1, 2, 3, 4, 5, and 6 hours postdosing, subjects rated their pain intensity, pain relief, and whether the pain relief was meaningful compared to baseline. A significant treatment effect was observed favoring Extra Strength BAYER Aspirin over TYLENOL with Codeine for pain intensity difference (PID), peak PID, summed pain intensity difference (SPID), pain relief, total pain relief (TOTPAR), time to taking backup medication, and time to meaningful relief. Extra Strength BAYER Aspirin (1000 mg) was superior to one TYLENOL with Codeine #3 in treating moderate to severe dental pain. Both medications were well tolerated.
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