Misuse Should Not Drive the Removal of Diphenhydramine, a Proven FDA-Reviewed OTC Medicine Used by Millions

"Millions of Americans rely on safe, effective over-the-counter (OTC) medicines containing the FDA-reviewed active ingredient diphenhydramine. When used as directed, these medicines provide well-established benefits for allergies, cold symptoms, motion sickness, minor skin irritations, and occasional sleeplessness.

"Common side effects, such as drowsiness or dry mouth, are also widely recognized by healthcare professionals and consumers and clearly disclosed on the Drug Facts label. It's important to underscore that these medicines are intended for responsible, short-term therapeutic use, not long-term or recreational use, and like all OTC medicines, should always be used as directed.

"The availability of newer antihistamines does not warrant removing a longstanding ingredient that millions of Americans safely rely on when used appropriately. It is also important to consider the patient perspective because people respond differently to treatments, and removing an ingredient used by individuals with moderate to severe allergies could leave them with fewer or no effective options to manage their symptoms.

"Reports of intentional misuse, including social media challenges involving extremely high doses, are also deeply concerning. Such behavior is dangerous and wholly inconsistent with the safe, directed use of OTC medicines. Misuse should not be confused with the appropriate, evidence-based use of these products. CHPA, along with its Health In Hand Educational Foundation, strongly supports continued efforts to educate parents, caregivers, and teens about preventing misuse and encouraging safe, responsible self-care practices.

"We encourage consumers to always read and follow the Drug Facts label and to speak with a healthcare professional if they have questions. Additional information on the safe use of OTC medicines, including diphenhydramine, is available through our Health In Hand Foundation at: www.HealthInHand.org."

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and OTC medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.