FDA approves label change for Prilosec OTC

ROCKVILLE, Md. The Food and Drug Administration last week approved Procter & Gamble’s proposed label change for Prilosec OTC.

The design changes include a new Prilosec OTC logo throughout the labeling, a reformatted 2-count professional sample card, a redesigned inner panel of the 2-count consumer sample card, a reformatted package insert and redesigned principal display panel.

The application did not include any changes to the Drug Facts or blister card backing. As part of the approval, P&G must remove “NEW LOOK! SAME RELIEF!” messaging prior to July 18.

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