Zyrtec-D: FDA Regulations, Composition & Safety Information

The allergy drug Zyrtec-D consists of cetirizine, an antihistamine, and pseudoephedrine, a decongestant. In 2007 the Food and Drug Administration approved the drug for treatment of allergy symptoms including sneezing, nasal drainage and urticaria, better known as hives. Because Zyrtec-D contains pseudoephedrine, it falls under federal restrictions regarding the quantity a customer may purchase. FDA records of complaints about Zyrtec-D concern labeling, advertising and manufacturing practices.

Recalls

• On July 15, 2009 the FDA issued an enforcement report listing Zyrtec-D on a recall, citing "non-conformance with Current Good Manufacturing Practices." Good Manufacturing Practices are federal standards for pharmaceutical labeling and production.

Warning Letters

• On April 13, 2005 the FDA issued a warning letter to Pfizer, Zyrtec-D's maker, for violating pharmaceutical advertising restrictions. According to the letter issued from Thomas Abrams, director of the Division of Drug Marketing, Advertising, and Communications, the advertising claimed Zyrtec-D was superior to other allergy products but did not substantiate the claim with clinical testing.

Combat Methamphetamine Epidemic Act

• The Combat Methamphetamine Epidemic Act restricts the sale of Zyrtec-D and pharmaceuticals of similar chemical composition. A customer may purchase no more than 3.6 grams per transaction. The buyer must supply photo identification at the time of purchase.