FDA Safety Page: Helping patients understand OTC labeling


The FDA recommends that you counsel patients on the importance of reading product labels carefully to determine the active ingredients and dosing instructions of each product and to discourage them from making assumptions about use based on product names or appearance. The use of similar trade names (so-called "brand-name families") is common practice for OTC products. The products with the trade names "Sudafed" and "Sudafed PE" illustrate specific concerns.

Sudafed is a well-recognized brand name that healthcare professionals customarily associated with nonprescription (OTC) drug products containing the active decongestant ingredient pseudoephedrine. Sudafed PE, containing the decongestant phenylephrine, is one of numerous products also bearing the Sudafed brand name. The packaging of Sudafed and Sudafed PE is similar in appearance, as are the tablets themselves. FDA finds this combination of factors may have contributed to patient errors, primarily among patients who mistakenly purchased and used Sudafed PE instead of Sudafed.

Further confusion has arisen over their dosage. The usual single dose of Sudafed is two 30-mg tablets-and of Sudafed PE, one 10-mg tablet. It has been reported to FDA that some consumers have administered twice the recommended dose of Sudafed PE, despite the highlighted area on the primary display panel that states the dose is "1 Pill/Dose." This confusion may be attributable to the packaging of Sudafed PE; each blister contains two tablets.

To help avoid Sudafed/Sudafed PE and other OTC prduct errors, these are some recommendations to consider when counseling your patients:

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