FDA approves Zyrtec OTC
This article was originally published in The Tan Sheet
The agency approves Zyrtec (cetirizine HCl) for nonprescription use, one week after it granted McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, approval to switch the allergy treatment's decongestant combination product, Zyrtec-D (1"The Tan Sheet" Nov. 12, 2007, p. 9). The prescription-strength product will be available OTC in stores starting in late January 2008, J&J says in a Nov. 16 release. The firm received approval for Zyrtec in 5 mg and 10 mg tablets, 5 mg and 10 mg chewable tablets and 1 mg/mL syrup. The once-daily drug is indicated for relieving indoor and outdoor allergy symptoms of sneezing, runny nose and watery eyes for up to 24 hours in adults and children; the drug also relieves itching due to hives, J&J says...
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