(WASHINGTON) -- The U.S. Food and Drug Administration Thursday asked drug manufacturers to limit the strength of acetaminophen, a drug commonly used in both prescription and over-the-counter medications, in their products. Combination prescription medications will be allowed to include no more than 325 mg of acetaminophen in each tablet or capsule.
The FDA's decision to restrict the drug's content level comes from acetaminophen's risk of severe liver injury as well as its associated allergic reactions.
Additionally, manufacturers of products containing acetaminophen will now be required to include a boxed warning emphasizing the potential risk of liver toxicity and a warning listing the drug's potential allergic reactions such as swelling of the face, mouth and throat, difficulty breathing, itching or rash.
The agency highlights that the action will only affect prescription medications (e.g., Vicodin, Lortab). Over-the-counter products used to reduce pain and fever (e.g., Tylenol) were not included in the FDA's decision.
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