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TUESDAY, Oct. 7 (HealthDay News) -- Saying they were acting "out of an abundance of caution," the makers of over-the-counter cough and cold medicines said Tuesday that the medicines should not be given to children younger than 4 years old.
In addition, the companies announced that they would be using child-resistant packaging and new measuring devices for the products, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, told reporters at a Tuesday afternoon teleconference.
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"This is another step in the reassessment of children's over-the-counter cough and cold medications that has been going on," Woodcock said. "We at FDA support these voluntary actions at CHPA [Consumer Healthcare Products Association]. We are continuing to assess the safety and efficacy of these products."
The FDA has also taken steps to revise the OTC monograph -- written in the 1970s -- for these medicines; FDA monographs help determine how a drug will be marketed. The new monograph will take into account new research, some of which has yet to be completed.
The FDA has had discussions with the OTC [over-the-counter] industry about changing labels, Woodcock said, and, recognizing that the rule-making process would take several years at best, supported this voluntary action.
There will be a transition period while the new labels replace existing labels on products on pharmacy shelves. So parents and caregivers should adhere to the actual labels on the products they have and should consult with their doctor or pharmacist if they have any questions, Woodcock said.
Use of the over-the-counter medicines has been controversial, with pediatricians criticizing the marketing of the remedies for children under 6, citing reports of safety problems -- even deaths -- and a lack of evidence that they work.
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