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On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness.
The other reason: Phenylephrine is technically approved by the Food and Drug Administration (FDA) as a decongestant—even though the organization has acknowledged that the medication is really ...
The Food and Drug Administration (FDA) is proposing to remove from the market a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work. The move brings FDA ...
Phenylpropanolamine (PPA), sold under many brand names, is a sympathomimetic agent which is used as a decongestant and appetite suppressant. [ 9 ] [ 1 ] [ 10 ] [ 11 ] It was previously commonly used in prescription and over-the-counter cough and cold preparations .
They was manufactured by Graham DM and both approved for use by the U.S. Food and Drug Administration in 1985. In 2000 the FDA issued an advisory for all products containing phenylpropanolamine due to the risk of stroke [2] and recommended their recall. Both Cold Capsule products are now Discontinued.
Dexatrim formula has changed considerably over the years. In prior formulations, Dexatrim contained the decongestant phenylpropanolamine (PPA) and the amphetamine-like compound ephedra. [13] A 2000 study by Yale University School of Medicine showed an increased risk of hemorrhagic stroke with taking PPA. [14]