The FDA is warning consumers about potentially serious side effects from mistakenly swallowing McNeil Consumer & Specialty Pharmaceuticals‘ Benadryl (diphenhydramine) Extra Strength Itch Stopping Gel. Benadryl Extra Strength Itch Stopping Gel is indicated for use on the skin, and is only safe and effective when used as directed. The FDA has received reports of serious side effects in patients who have mistakenly swallowed the product. Patients swallowing the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations, and confusion.
McNeil Consumer & Specialty has taken the following actions to help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for topical use on the skin only:
- Changed the product label to add a new, prominent statement “For Skin Use Only.”
- Attached a sticker to the cap of the product that says “For Skin Use Only.”
- Initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel
The repackaged product is currently available in pharmacies and retail stores.
For more information visit www.fda.gov/ForConsumers/ConsumerUpdates/ucm211432.htm.