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No More Concentrated Infant Formula of OTC Acetaminophen

Andrew McCaul

Ever been confused about exactly how much Tylenol to give your kid? Over-the-counter drug manufacturers announced this week that they will no longer produce acetaminophen in concentrated infant drops; all liquid acetaminophen products for kids under 12 will be available only in a 160 mg/5 mL concentration. Currently, consumers can purchase more than one concentration of OTC pediatric liquid acetaminophen in the U.S.: concentrated infant products (80 mg/0.8 mL and 80 mg/1.0 mL, sold with droppers) and formulations for children ages 2 to 11 (160 mg/5 mL, sold with cups). The various concentrations have led to inadvertent dosing errors among parents and caregivers.
Plus: New AAP Guidelines on Treating a Fever 

The chief trade group for OTC drug makers, the Consumer Healthcare Products Association (CHPA), said that the change was to avoid this confusion that might lead to accidental overdose, which is an unfortunately common occurrence. Once production ends later this year, the drug companies will sell a single formula for all children under the age of 12, although manufacturers have warned that there will be a period of transition where multiple concentrations of the infant products may be available in stores and in medicine cabinets simultaneously, so parents and caregivers should be sure (as always) to carefully read the product labels. Eventually, infants’ products will have syringes for more accurate dosing and flow restrictors, while children’s products will continue to be available with dosing cups, but both will have the same formulation.
Plus: Ease Baby's Pain After Vaccinations or Heel Sticks 

At the same time, the FDA also issued final guidance for the production, marketing and distribution of liquid OTC pain relievers, cold medicines, cough syrups and digestion aids that are measured and dispensed with spoons, cups, or droppers included in the packaging. Among its main recommendations, the FDA stated that dispensing devices should be marked with calibrated units of liquid measurement (for example, teaspoon or milliliter) that match the units of measurement specified on the label instructions, and should not have any unnecessary markings. Additionally, the markings on dispensing devices should be clearly visible when the liquid medicine is added to the cup, dropper, etc. 

Have you ever been confused (late at night, when your kid’s spiking a fever) about how much medicine to give? Do you think this will help?

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