Benadryl Extra Strength Itch Stopping Gel has been labelled as having "serious side effects" by the US Food and Drug Administration (FDA).
The organisation noted that the over-the-counter medication is supposed to be used on the skin, but it has caused a number of problems in those who mistakenly consume the product.
According to the FDA, individuals who ingest it may experience hallucinations, confusion and unconsciousness due to the dangerous levels of diphenhydramine it contains.
Director of the body's division of medication error prevention and analysis Carol Holquist said "consumer confusion" is at the root of the problem.
"FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed," she went on to say.
The institution recently launched a new initiative to combat misleading prescription drug advertising by educating health care providers on their role in recognising and reporting such issues to regulators.
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