WASHINGTON — Makers of over-the-counter, single-ingredient liquid acetaminophen medicine for children plan to transition these pediatric products to one concentration, according to the Consumer Healthcare Products Association (CHPA).
CHPA said Wednesday that under the voluntary change by manufacturers, the current children’s strength of liquid acetaminophen (160 mg/5 ml) will become the only liquid concentration available for all children under age 12, and the current concentrated infant drops will no longer be sold. Right now, families can buy more than one concentration of single-ingredient pediatric liquid acetaminophen in the United States.
Plans call for the transition to start in mid-2011, according to CHPA. In the interim, parents and caregivers can continue to use the current pediatric over-the-counter medicines, whose labeling and dosing instructions are accurate for safe and appropriate use, the association said.
"CHPA member companies are voluntarily making this conversion to one concentration to help make it easier for parents and caregivers to appropriately use single-ingredient liquid acetaminophen," CHPA president and chief executive officer Scott Melville said in a statement. "We are committed to providing parents and caregivers with the tools and information they need to help give their children the right amount of these medicines."
Public and government concern has risen in recent years about the safety and efficacy of pediatric OTC medicines, especially for very young children, as well as about overuse of acetaminophen by both children and adults. Concerns centered on confusion over dosing instructions and parents exceeding the recommended dose, as well as people inadvertently taking too much of the pain reliever/fever reducer, which is often found in multisymptom OTC or prescription products they may also be using.
CHPA said that during the switch to the uniform concentration, OTC medication manufacturers will work with retailers to ensure that the more-concentrated infant drops will be removed from store shelves as the new medicines are introduced.
The association also noted that there will be a time period when both concentrations of infant liquid acetaminophen products — the concentrated drops and the new 160 mg/5 mL concentration — will be in stores and in medicine cabinets. As a result, consumers will be urged to always read and follow the label and pay attention to the concentration, especially when a health care provider gives dosing instructions.
CHPA added that the single-concentration liquid medicines will have additional enhancements to their age-appropriate dosing devices. Infant products will have syringes for more accurate dosing and flow restrictors. Children’s products, for ages 2 to under 12 years, will continue to offer dosing cups.
