OF HEALTH AND HUMAN SERVICES Food and Drug

The Food and Drug Administration (FDA) is proposing new warning labeling for all over-the-counter (OTC) drug products containing phenylpropanolamine preparations (phenylpropanolamine bitartrate, phenylpropanolamine hydrochloride, and phenylpropanolamine maleate). Phenylpropanolamine is a sympathomimetic drug that is used in OTC weight control, cough-cold, nasal decongestant, and allergy drug products. The warnings will advise consumers not to take more than the recommended dose of phenylpropanolamine, not to take phenylpropanolamine with certain prescription drugs, and not to take phenylpropanolamine under certain conditions. The warnings will also advise consumers that they should not take a phenylpropanolamine drug product with any other drug product containing the ingredients phenylpropanolamine, phenylephrine, pseudoephedrine, or ephedrine, which are sympathomimetic drugs commonly found in allergy, asthma, cough-cold, nasal decongestant, and weight control drug products. These drugs could be harmful if taken together.