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Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors

Audience: Consumers, Pharmacists

Johnson & Johnson and FDA notified consumers and healthcare professionals of changes to the graphics and information displayed on the front of the product container to reduce the risk of serious side effects from swallowing the topical Benadryl Extra Strength Itch Stopping Gel intended "For Skin Use Only". FDA received reports of consumers ingesting the gel rather than using it topically. Swallowing the gel can result in people receiving dangerously large amounts of the active ingredient diphenhydramine.

Between 2001 and 2009, 121 cases of ingestion of Benadryl Extra Strength Itch Relief Gel were reported to the manufacturer. Of these cases, 7 were considered serious because patients required treatment in the emergency room, hospitalization, or admission to the intensive care unit. Others reported adverse events included hallucinations, unconsciousness, sleepiness, difficulty walking, dizziness and inability to speak.

[05/12/2010 - Drug Safety Communication - FDA]

[05/12/2010 - Consumer Update - FDA]

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