Sominex controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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1979
Methapyrilene safety controversy
Older U.S. Sominex formulations contained methapyrilene. After preliminary animal research associated high-dose exposure with liver tumors, federal officials urged removal or reformulation of affected over-the-counter products, including Sominex.
1975
Sominex 2 regulatory and labeling dispute
California officials and the FDA challenged Sominex 2 over warnings, child-resistant packaging, and the then-regulatory status of diphenhydramine in an OTC sleep aid. The FDA ordered remaining stock removed.