The Procter & Gamble Company (Procter & Gamble) herewith submits, in triplicate, comments in response to the final rule: labeling of oral and rectal over-the-counter (OTC) drug products containing aspirin and nonaspirin salicylates; Reye’s syndrome warning, published on April 17,2003 in the Federal Register (Vol. 68, No. 74, pages 18861-18869). Procter & Gamble, as a manufacturer and distributo...

All drugs should be given with caution to pregnant or breast feeding women. Recent concern about the role of salicylates in the aetiology of Reye's syndrome has prompted the DHSS to restrict the use of aspirin in children. The case of a 9 week old breast fed infant whose serum contained 0.47 mmol/l of salicylate is reported. Her mother was taking aspirin 2.4 g/day, and it is concluded that sali...

Sodinin salieylate consistently produces a prompt increase in heart contractile force when injected in anesthetized dogs in doses of 100 mg./Kg. intravenously. The increase in force is about 30 per cent and declines to control levels in 15 to 20 niin. This effect is not considered of important therapeutic significance. Total doses of about 400 mg./Kg. consistently produce marked hyperpyrexia wh...