A Focus on OTC Safety

Concern over pediatric OTC cough and cold products creates interest in accurate dosing.



By David Vaczek
Senior Editor


AccuDial plans to launch nine cough and cold OTCs using its rotating weight-based dosing label that delineates doses in 0.5-ml increments.

Amid ongoing industry attention over the safety and efficacy of children’s over-the-counter (OTC) cough and cold products, OTC manufacturers have come out in favor of new labeling and packaging that includes dosing devices to help reduce dosing errors.

The Consumer Healthcare Products Association (CHPA) said last month that members will voluntarily adopt labeling for these products that says “do not use” in children under 4 years of age. Labeling will also warn parents against using allergy-relieving antihistamines to make children sleepy.

In stating its support for CHPA’s decision, FDA said the new labeling will not affect availability of the medicines, but there will be a transition period where some medicines will instruct against use in children under 2 years. FDA required labeling warning against use in children under 2 years in an advisory this past January.

The agency said it will continue to evaluate children’s cough and cold products, as it completes the process of revising the OTC monograph for children’s cough and cold OTCs. The monograph lists approved ingredients, amounts, and usage rules for the medicines.

Physicians and consumer groups have argued that the products have not been shown to be safe and effective. As FDA has sought feedback to support its rule making, some pediatricians have called for an all-out ban on the OTCs, or that they be designated as prescription drugs.

FDA, however, has expressed concern that an immediate ban would lead parents to give adult medicines to children.

In October 2007, manufacturers voluntarily recalled 14 brands of cough and cold products intended for children under 2 years of age.

Studies by the Centers for Disease Control and Prevention and a comprehensive safety review by FDA in 2007 showed that most bad reactions to OTC pediatric cough and cold medicines result from accidental ingestion.

CHPA is exercising “an overabundance of caution” with the label changes. “We feel this is the best move at this time to ensure these medications are used as intended as we are entering the cough and cold season,” says Elizabeth Funderburk, CHPA director of communications.

“These are medicines with real benefits. We as an industry hold the position that these medications are safe and effective when taken as directed. [But] consumers need to know how to administer and store them safely,” she adds.

“[Research] shows that the majority of [adverse events] are from accidental ingestion. We know that the vast majority of adverse events are happening in children under the age of 4 years,” Funderburk adds.

CHPA has announced a multiyear, national consumer education program aimed at reducing preventable errors. The program will underscore the importance of following the label directions, using the correct dose, storing the medicines correctly, and consulting with professionals if more help is needed.

CHPA will also further study the medicines’ efficacy, with pharmacokinetic studies to confirm dosing for eight of the most commonly used ingredients. Members also will undertake research to revalidate the medicines’ effectiveness.


In response to the continuing concerns around pediatric liquid cough and cold medications, Comar Inc. (Buena, NJ) has launched a dosage cup with printed measurement markings that is commercially available as a custom or stock design.

For pediatric or general OTC and prescription packaging, the AccuCup features measurement markings with cured, durable FDA-compliant food-grade inks for applications requiring “clearly visible accuracy,” the company says.

The cup print markings can be easier to read than markings on molded-embossed or standard thermoformed cups, particularly in low light conditions such as in a bedroom. Also, custom print markings support accuracy relative to synchronizing with the packaging label instructions, says Dennis Paris, director of marketing.

“We had offered this printing only for custom OTC brand applications in the past,” Paris says. “Now, customers with custom print requirements for calibration, logo, and instruction markings will enjoy the benefit of package synchronization, branding, affordability, and quick turnaround on purchase volumes.”

The AccuCup is offered in a stock standard cup design with generic print markings up to 4 tsp/20 ml, as well as in a standard blank molded cup design for the printing of custom calibrations and markings. Comar has added a second molding and printing line as it inventories the format-ready supply, Paris says.

Customers can choose to have custom cores made for custom rib configurations supporting a snug fit of the cup on a closure up to 24 mm.

Through recent production-line expansion, Comar is offering four- to six-week lead times on its Comar Oral Dispenser (COD), a patented two-piece syringe system for pediatric liquid dosing. The positive-displacement device supports accurate dosing and is designed for child safety by eliminating the detachable rubber plunger tip. The COD can be used with a press-in bottle adapter for no-spill drawing of the liquid from an inverted medication bottle, improving child safety by restricting the flow of the liquid medication from an open bottle.


Comar is offering the AccuCup, a printed dosing cup, as standard stock. Cup ribs can be molded for snap- or friction-fit seating to bottle closures.

AccuDial Inc. (Palm Beach Gardens, FL) is focusing on weight-based dosing for children’s OTC medications with a bottle label from CCL Label (Hightstown, NJ) that rotates to enable the caregiver to find the correct dose.

The company is launching a line of pediatric pain and fever, allergy, and cough and cold medications exclusively offering the weight-based dosing label.

“Underdosing is also an issue. When children are underdosed, symptoms reappear before the next scheduled dosing, so the child is not getting the therapeutic benefits of the drug for the treatment duration,” says CEO Robert Terwilliger.

Labels typically provide dosing directions based on age ranges with the result that one age segment receives the effective dose, and the rest are under dosed following the label instructions. Weight-based dosing ensures safe and effective dosing, Terwilliger says.

“One study has shown that 52–62% of children are underdosed with OTC medications. Typical labels do not have the space to accommodate more detailed dosing instructions. The AccuDial label will offer the finest granularity for weight-based dosing on the market,” he adds.

The label’s dosing instructions are in 0.5-ml increments, for patient weights delineated in 2-lb increments from 24 to 100 lb. The patented-system features a base label with weight and dosing information. The user rotates a twist label with a clear window to find the proper dose for the selected weight. The system features a dosing spoon calibrated in ½ ml increments matching the dosing instructions on the bottle.

Since adopting the new voluntary labeling by CHPA members, a label redesign includes the do-not-use-under-4-years-of-age designation, and removal of dosing information for children under 4. AccuDial is working with companies to source the bottle, which has been redesigned with a ridge to hold the label in place for more accuracy, he says.

AccuDial plans to launch and market 2 analgesics; 2 allergy products; and 5 cough, cold, and sinus medications.

The firm has lined up product supply and packaging agreements with generic and brand manufacturers, and is working with regulatory bodies in the United States, Canada, and Europe for the products’ approval, Terwilliger says.

“We are working with six different FDA and EMEA-certified drug manufacturers in the United States, Canada, and Europe. We will have more than one manufacturer for every product,” says Terwilliger.
“We have filed for approval for three products initially with Health Canada, and anticipate approval, after which we will submit the remaining products. We will be filing abbreviated new drug applications [ANDAs] in Canada for our ibuprofen and loratadine products, and are working with FDA to obtain approvals on the full line in the United States,” says Terwilliger.

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