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THURSDAY, May 13 (HealthDay News) -- The U.S. Food and Drug Administration has alerted consumers regarding potentially serious side effects associated with mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product intended only for topical use.
The FDA issued the warning after receiving reports of adverse events in individuals who mistakenly swallowed the product. While many OTC Benadryl products are intended for swallowing, Benadryl Extra Strength Itch Stopping Gel is only intended for topical use. People who swallow it can take in unsafe amounts of the active ingredient, diphenhydramine, which can lead to unconsciousness, hallucinations and confusion.
Johnson & Johnson, the manufacturer of Benadryl Extra Strength Itch Stopping Gel, has already changed the product label to add a new, prominent statement, "For Skin Use Only." In addition, a sticker was added to the cap of the product that also states "For Skin Use Only."
"Consumer confusion and incorrect product use are serious public health issues," Carol Holquist, director of the FDA's Division of Medication Error Prevention and Analysis, said in a statement. "FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed."
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