FDA Halts Production on Cough Medicines
May 2007
The Food and Drug Administration (FDA) has ordered companies that
produce cough medicine containing guaifenesin in timed-release formula
to cease production and shipping before the end of 2007. Guaifenesin is
a substance that stimulates the removal of mucous from the lungs in
cough and cold sufferers.
About 20 different companies manufacture extended-release guaifenesin products without official FDA approval. Often, these products contain other cough and cold suppressants in combination with guaifenesin. Production must be ceased before the end of August, and shipping must end before the last days November.
The FDA requires that all timed-release medications undergo review to ensure their safety of dosage and effectiveness. This current order does not apply to immediate-release medication with guaifenesin.
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Source: "FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products." FDA Press Release. May 25, 2007.
