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AccuDial, Inc.



FDA Cites Dosing Errors in New Recommendations for Children's OTC Medications



October 31st, 2008

Underscoring the importance of weight-based dosing for over-the-counter (OTC) children's medications, the Food and Drug Administration (FDA) recently announced its recommendation that cold and cough medications be relabeled: "For Children Ages 4 and Up."

Emphasizing that dosing errors and accidental ingestions are the leading causes of adverse events in children related to cough and cold ingredients, OTC manufacturers voluntarily agreed to change the dosing directions, according to the Consumer Healthcare Production Association (CHPA).

Dosing by age rather than weight is a core issue of the safety and efficacy of cough/cold products for children....


Source: Health Business Week (2008-10-31)

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