Comments to FDA: CP Requesting a Warning Label for Nonprescription Drug Products Containing an Ingredient with "Anticholinergic or Histamine H1 Inverse Agonist Effects"

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Docket Number:
FDA-2013-P-1001

The Petitioners request that the Commissioner of Food and Drugs add a warning to the labeling of all nonprescription drug products containing an ingredient with “anticholinergic or histamine H1 inverse agonist effects” noting that the product can cause a confusional state.

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