Download Download this free, 150-page Pharmaceutical Serialization Playbook jam-packed with strategies for success and pitfalls to avoid.  Learn more >>
Article |

FDA proposes additional warning on some OTC drug labels

The Food & Drug Administration wants an additional warning on over-the-counter (OTC) drugs containing phenylpropanolamine (PPA), a common ingredient in weight control, cough-cold, allergy and nasal decongestant drugs.
Print Reprint
FILED IN:  Machinery  > Labeling

The proposed new warning would advise against taking more than the recommended dose or taking PPA-containing drugs with others also containing PPA phenylephrine pseudoephedrine or ephedrine. Labels for PPA weight control drugs would state they are to be taken only by those over 18 years old and that higher doses will not cause additional weight loss. The agency also is proposing that OTC drugs list sodium content and is working with pharmaceutical organizations to develop voluntary sodium labeling for prescription drugs. Labels would list total sodium content if it exceeds 5 mg and a statement would be added to the warning section if sodium exceeds 140 mg.


Add new comment

Related Sponsored Content

42 Best Package Designs
Sign up to receive timely updates from our editors and download this e-book consisting of our editors' picks of most notable package designs. Updated for 2014!


Don't miss intelligence crucial to your job and business!
Click on any newsletter to view a sample. Enter your email address below to sign up!
Each newsletter ranges in frequency from once per month to a few times per month at most.