Code of Federal Regulations Title 21. Food and Drugs § 21.369.9 General warnings re accidental ingestion by children

Section 369.20 includes under certain items, but not all medicines, the statement:  “Keep this and all medicines out of children's reach. In case of overdose, get medical help or contact a Poison Control Center right away,” or “Keep out of reach of children.” However, in view of the possibility of accidental ingestion of drugs, it is not only suggested but is recommended that one of these statements be used on the label of all drug products.