The FDA said today it has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg) as an OTC product for adults and children 12 years of age and older.
Zyrtec-D will be distributed by Johnson & Johnson's unit McNeil Consumer Healthcare, which acquired OTC rights to the drug when Pfizer's Consumer Unit was purchased by J&J in 2006 for just over $16 billion.
Zyrtec-D combines the antihistamine, cetirizine, with the nasal decongestant, pseudoephedrine, and is indicated to treat hay fever or other upper respiratory allergies.
Sales of OTC Zyrtec-D will be subject to restrictions implemented under the Combat Methamphetamine Epidemic Act which places restrictions on the sale of products containing pseudoephedrine. Those restrictions include limiting the amount of pseudoephedrine-contatining products an individual can purchase and imposing record-keeping requirements on pharmacy and retail establishments selling the products.
In large amounts, pseudoephedrine can be used to make the illegal drug methamphetamine.
Hay fever and other allergies are the sixth leading cause of chronic disease, with about 50 million sufferers in the US, according to the National Institutes of Health.