The FDA is limiting the amount of acetaminophen that can be used in prescription painkillers to 325 mg per dose.
The agency is also requiring a boxed warning highlighting the risk for severe liver injury associated with prescription drugs containing acetaminophen (e.g., Vicodin, Lortab, Tylox, Percocet). The drugs’ labels will also carry a warning about the risk for allergic reaction.
The FDA asks clinicians to caution patients not to exceed 4 grams of acetaminophen daily and not to drink alcohol when using acetaminophen products.
Source: FDA MedWatch