WASHINGTON - Manufacturers of unapproved extended-release cough and cold drugs that contain an expectorant called guaifenesin have until Nov. 25 to stop shipping the medicines, health officials said Friday.
The Food and Drug Administration said roughly 20 companies make hundreds of timed-release medicines containing guaifenesin that have never undergone agency review. They are expected to stop making the drugs even earlier, by Aug. 27. The drugs are sold both by prescription and over the counter, and as both single-ingredient and combination products.
Friday's action does not affect products containing guaifenesin in immediate-release form, the FDA said. The agency said …
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