Kids' OTC Cough, Cold Meds to Get New Labels--October 2008

Article

As modified labels for oral OTC pediatric cough and cold medicines begin hitting pharmacy shelves, pharmacists are in a unique position to educate parents and caregivers on potential treatment options for this class of medicines.

Retail pharmacies are doing their part to educate the public about the latest label changes for oral OTC children’s cough and cold medicines. Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves these medicines with the new labels and packaging.

A recent FDA public hearing on the issue prompted leading manufacturers of these medicines to voluntarily transition the labeling on oral OTC pediatric cough and cold medicines to state “do not use” in children younger than 4 years of age; these modified labels will continue to provide dosing information for children 4 and older. Furthermore, for products containing certain antihistamines, manufacturers are voluntarily adding new language that warms parents not to use antihistamine products to sedate or make a child sleepy, according to a statement issued by Linda Suydam, president of the Consumer Healthcare Products Association.

Efforts by CVS/pharmacy and Walgreens to inform individuals of the FDA’s recommendations and pending label changes include in-store signage in the cough and cold section. Individuals also are encouraged to speak with CVS and Walgreens pharmacists about potential treatment options for cold and allergy symptoms in children under age 4. Both retailers will have the newly labeled products on store shelves as they become available from manufacturers. CVS/pharmacy said that it will continue to keep current versions of the 130 products it offers available for individuals until the new versions become available.

For other articles in this issue, see:

Survey Finds Patients Wary of Rx Switches

Rogue Pharmacy Crackdown Expected to Become Law

PDPs for Low-Income Beneficiaries Decreasing in ’09

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