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FDA Needs to Counter Misleading Information

Provide a statement to the public explaining that over-the-counter antitussive, expectorant, nasal decongestant, antihistamine and combination cough and cold products have not been shown to be safe and effective for the treatment of cough and cold in children under six years of age.

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FDA Needs to Counter Misleading Information

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  1. Provide a statement to the public explaining that over-the-counter antitussive, expectorant, nasal decongestant, antihistamine and combination cough and cold products have not been shown to be safe and effective for the treatment of cough and cold in children under six years of age.

  2. FDA Needs to Counter Misleading Information • Consumer Healthcare Products Association: • Letter to Editor, Baltimore Sun, 11/4/2006 • “Scientific data … indicate that OTC medicines are beneficial in relieving symptoms and help people of all ages feel better faster.” • “The label clearly spells out what a medicine is for, what active and inactive ingredients it contains, how much and how often it should be taken or given, and what the warnings are.” • Website, October 11, 2007 • “These medicines are safe and effective when used as directed.”

  3. Notify manufacturers of these products whose labeling 1) uses such terms as “infant” or “baby,” or 2) displays images of children under the age of 6 that: • Such marketing is not supported by scientific evidence; and • Manufacturers will be subject to enforcement action at any time.

  4. Amend 21 CFR 341 to require that labeling for over-the-counter antitussive, expectorant, nasal decongestant, antihistamine, and combination cough and cold products state: • These products have not been found to be safe or effective in children under 6 years of age for treatment of cough and cold. • These products should not be used for treatment of cough and cold in children under 6 years of age.

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