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Dr. Gollup's Pediatric Housecall

Dr. Howard Gollup is a board-certified pediatrician with Aurora Advanced Healthcare in Germantown. He cares for children from birth through adolescence. Though he cannot respond to individual medical questions, he welcomes your feedback and suggestions for future topics.

The New Acetaminophen Infant Suspension--A Dose of Caution!

acetaminophen, infant drops, fever, tylenol, suspension

Acetaminophen has been a mainstay for treatment of childhood fever and pain for fifty years. It played second string to “baby aspirin” for many years until, in the early 1980’s. At that time, Reyes Syndrome, a rare but serious childhood metabolic condition, was linked to aspirin use in children with influenza or chickenpox. So, acetaminophen became the called primary option for fever and minor discomfort. Even when children’s ibuprofen (Advil®, Motrin®, etc.) entered the scene later in the 1980’s, acetaminophen remained the more popular, trusted, and time-tested choice.

The best known brand of acetaminophen is Tylenol®. It enjoys that sort of name recognition that makes it synonymous with the very product, in the same way that facial tissues are called “Kleenex”® and adhesive strips are Band-Aids®.

Recently, the Consumer Healthcare Products Safety Commission announced that Infant Acetaminophen drops, which are more concentrated than Children’s Acetaminophen suspension, will no longer be manufactured. The reason is there has been concern that parents might give their children the concentrated infant drops using the volume guidelines for the children’s suspension, which would result in an overdose because the drops are about four times more concentrated.

The new infant suspension will have 160mg of acetaminophen per 5 milliliters (mL), just like the current children’s suspension. 5 mL is approximately 1 teaspoon, but the dosage will be expressed in mL to prevent people from using kitchen teaspoons, which are inconsistent and inaccurate. The older concentrated drops contain 80mg per 0.8 mL. Other than the new infant formulation coming with a dosage syringe, whereas the children’s suspension, which has a dosage cup, I don’t know if there is any difference in flavor or package size.

For awhile, both infant drops and infant suspension will both be on pharmacy shelves, and certainly will be in the medicine chests of many homes. So, it will be critical for parents to know exactly what they have. Although this change is intended to decrease confusion and medication errors there is potential to result in considerable confusion over the next few years.

I went to an “unnamed large chain pharmacy” this week to see what is currently on the shelves. There were many different manufacturers of infant acetaminophen concentrated drops as well as children’s suspension. However, I did not see any of the new infant suspension—not even from McNeil, manufacturer of Tylenol®, who has been proactively publicizing this change. McNeil has said that some of the new Infant Suspension may already be on the shelves.

Dosage instructions for children under two years will continue to be absent from the infant suspension packages. The package will continue to recommend consulting your child’s doctor for this information. Guidelines for infant dosing can often be found online. Always use a medication measuring device such as a medication syringe when dosing medication. Dosing is best expressed in mL since that is how the enclosed syringe will be calibrated. The dose is also best determined by your child's weight, with age being a rough approximation.

Typical guidelines for the new 160mg/5mL Infant Acetaminophen suspension will be:

Weight (lb) Age (mos) Dose (mL)
6-11 lbs 0-3 mos 1.25 mL
12-17 lbs 4-11 mos 2.5 mL
18-23 lbs 12-23 mos 3.75 mL
24-35lbs 24-36 mos 5 mL

Be very mindful about which preparation you purchase and which you currently have. Call your child's doctor if you think your child is quite ill. For the youngest infants, especially under 4 months of age, it is generally advised to call your child's doctor if you are concerned about any illness, for which you consider giving acetaminophen necessary. I've included the above table for your convenience, not as treatment advice (gotta say that!)

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