Published on the Packaging World Web site
| July 31, 1996
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.
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.
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