Adding Drug Facts Panels Without Pain

The maker of Tylenol tripled labeling space through creativity and teamwork.


Erik Swain, Senior Editor

Added flaps increase labeling space, not pouch size.

Thanks to FDA's mandate that over-the-counter (OTC) drug labels feature a larger type size and a less cluttered layout, the agency's new Drug Facts format has forced changes to a lot of packages. More room must be created to accommodate all the required information. The small pouches used by McNeil Consumer & Specialty Pharmaceuticals Division of McNeil-PPC Inc. (Fort Washington, PA) were no exception.

The pouches, with dimensions of 2.5 x 2.5 in. or a similar size, are used for small quantities of Tylenol tablets and other McNeil products and are popular with consumers. So discontinuing the smallest package sizes, which a few firms have done in lieu of coming up with new package designs, was not an option for McNeil.

The obvious solution, increasing the size of the pouch, was not acceptable either because of costs, says Eric Widor, a staff packaging engineer at McNeil. Not only would material costs have doubled, but new tooling would have been needed for the pouching machines. "We saw that nothing on the market at that time would work to meet all our requirements," he says. "So we made it a development project."

Widor and his team turned to their primary supplier of pouch material, RJR Packaging (Winston-Salem, NC), for help with a solution that would meet all the Drug Facts labeling requirements without increasing the size of the pouch, requiring new tools, affecting stability, or compromising line speed. It was a tall order.

"We were dedicated to making pouches work," says Widor. "We saw it as a competitive advantage in making this work. We were going to do this no matter what."

Together, McNeil and RJR Packaging developed a patent-pending pouch design. In general, two additional panels are permanently sealed along the bottom edge of the pouch. Each panel lies adjacent to one side of the pouch and is removably adhered to its edge. A consumer can open the flaps along the top edge to reveal the Drug Facts information printed on the panels, and then reseal them.

"All the while, we have still maintained the integrity of the pouch holding the product," Widor says.

Even though the pouch is the same size as it was before, the available printing space on the outside has tripled. There are now six panels that can be used for graphics and labeling, where there used to be two. For nondrug products that don't need the Drug Facts box, the extra panels can be used for coupons and the like. The extra panels add slightly to material costs, but not as much as increasing the overall size of the pouch, and without loss in productivity or the need to purchase new equipment.

"There's a heat-activated seal at the bottom, and it's not sealed until it's at the copacker," says Scott Super, account manager for RJR. "It can work with a wide variety of sealant materials, from Surlyn to LDPE [low-density polyethylene]. Also, several different barrier materials could be chosen for use."

The product was tested at the Clifton, NJ, facility of Caraustar Custom Packaging Group (Austell, GA), where McNeil has most of its small pouches made. They found it could be run on Caraustar's existing equipment without losses in speed. "Their equipment offers a lot of control over heat and other factors, regardless of what type of seal you're using," Widor says.

Although both pouch package and the method for its manufacture are the subject of a pending patent application, RJR Packaging will be able to offer the six-panel pouch to other customers, in hopes that it can work as well as it did for McNeil.

"Because of this design, we were able to retain our presence in a large piece of the retail market," Widor says. "It was well worth doing."

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