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Reporting a Medication Error

Know where to look for OTC label ingredients

339a0e1449b6b4062056bc300d87e893 MThere is evidence that some patients (and perhaps even health professionals) may not recognize that FDA-required facts about over-the-counter (OTC) medications, including dosing information, are often on a peel-back label that is stuck to the bottle.

Following a fall, a patient received a prescription for a strong narcotic for severe pain. As many readers know, narcotic drugs like morphine, HYDROcodone, codeine and others, can often cause constipation. Sometimes it is pretty bad, causing people to strain too hard when they go to the bathroom. To prevent this, the patient's doctor told him to buy a product called MIRALAX (polyethylene glycol 3350), to prevent constipation.

When the patient went home, he called his son, a pharmacist, to ask how to use the Miralax. He told his son that he couldn’t find any directions on the product label. The pharmacist was surprised by that and decided to go to a local pharmacy to view the product himself. However, the son was also unable to find any dosing directions. It turns out that directions for use of the product, as well as other drug facts, are underneath a label overlay that must be peeled back to expose the information. There is a small icon and the words “peel here” in the far upper right-hand corner, about 180 degrees opposite the front label panel. You can see it in this photo:

This is not the first time that a patient has failed to recognize the need to peel off the label for available drug facts, which we have reported to FDA. We encourage manufacturers to include dosing information on the front panel or, at a minimum, to prominently display the need to peel back the label.

We hope that OTC manufacturers will examine this issue and develop educational tools for display at pharmacies and other locations where OTCs are sold. It’s also interesting that a store brand substitute product at the same pharmacy had visible instructions on the label without peeling it back. Perhaps there should be a requirement for all products to have a standard minimum amount of information immediately visible.

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