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Safety information on Infant and Children’s Tylenol

The makers of Tylenol are rolling out new packaging for its infants’ and children’s products to make dosing the medication easier and safer. Overdosing of the active ingredient – acetaminophen – in the products can lead to liver damage.

In the wake of product recalls over the past year, McNeil Consumer Healthcare is taking steps to improve product safety and, in the case of kids’ over-the-counter medications, standardize the concentration across all infants’ and children’s acetaminophen products on the market. McNeil has worked closely with the Consumer Healthcare Products Association to share its plans with other manufacturers. Changes to its Infants’ and Children’s Tylenol are expected before the next cold and flu season.

Better dosing accuracy to reduce risks


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“The existing products are safe and effective when used as directed and, while most parents and caregivers use pediatric acetaminophen products appropriately, there have been instances where caregivers confused the Infants’ and Children’s concentrations,” says Dr. Edwin Kuffner, vice president of OTC Medical Affairs & Clinical Research for McNeil Consumer Healthcare. “Our goal is to reduce this occurrence by standardizing dosing across our products and age groups.”

Dr. Kuffner says plans for safety improvements are not related to any recall action. He has represented McNeil at multiple FDA advisory committee meetings on topics including the safety and efficacy of acetaminophen, phenylephrine and pediatric cough and cold medicines.

“As part of McNeil’s commitment to consumer safety, we are constantly looking for ways to innovate and provide caregivers with the best possible products,” he says.

Push-in syringe for Infants’ Tylenol

Packaging improvements will make administering the medication easy and exact. They’ll also help keep children from getting into the bottle themselves. The new Infants’ Tylenol bottle will have a protective opening and a new push-in syringe instead of the dropper. Parents can insert the syringe into the bottle top to draw out the right dose, allowing for better control and reducing spillage — easy! It’s especially helpful when you’re tired and up in the middle of the night when your child is fighting a bad cold.

Children’s Tylenol will also have an improved protective opening and dosing cup – no need for teaspoons.

Tips for giving medication to kids: Simply remember to ‘NURSE’

  • Never give adult medicines to children.
  • Use the measuring device (syringe, dropper, dosage cup) that comes with the medicine every time you use it. Don’t use kitchen spoons (teaspoons or tablespoons).
  • Read and follow instructions on the label. Never give more than the recommended dose and do not give the medication more frequently than recommended.
  • Store all medicines out of the reach of children. Immediately following use, always restore the child-resistant cap and put the medicine back into a high and out-of-sight location.
  • Every child grows. Know the infant’s or child’s weight and/or age to help determine the appropriate dosage.

More on children’s cold and flu treatments

Child vs. infant medication
What to do when your baby catches a cold
All-natural cold and flu remedies

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