The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions

Origin/Publisher:

FDA

Content:
FDA is informing manufacturers, members of the medical and scientific community, and other nterested persons that at this time we do not intend to object to the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing a warning as described in this guidance (see section III, Discussion and Policy) alerting consumers that the use of acetaminophen may cause severe skin reactions

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK