FDA Considers Putting Dosing Info on Baby Meds -- It's About Time!

Apparently, I’m not the only one who thinks it’s ridiculous that the dosing information on Infant Tylenol reads "Under 24 months: Consult your child's doctor," because the Food and Drug Administration (FDA) meets today to "consider whether they have enough information to add dosing instructions for children between the ages of 6 months and 2 years."

As a mother and Registered Nurse, I’ve always wondered why in the world you would sell a product for babies, and then neglect to include instructions for how to use it safely -- for babies. Sure, we've all found ways around the lack of instructions, like consulting an online dosing chart at 2am so you don't have to call your doctor and have her tell you what you already know: that it's okay to treat your baby's fever.

To further simplify matters, Johnson & Johnson, makers of Tylenol, have announced that they will phase out infant formulations all together. By the end of this year, they will only sell one formulation of Tylenol for all kids under age 12.

Again, I say -- what a relief. Infant Tylenol drops are incredibly concentrated: 1.6 milliliters of the medicine contains 160 milligrams of acetaminophen. Children’s Tylenol – the stuff in the bottle -- contains 160 milligrams of Tylenol in 5 milliliters. I get it: Smaller doses are easier to get down smaller babies. But having different strengths of the same medication in the house can confuse even experienced parents and educated healthcare consumers like me.

It's better to have one bottle in the house with clear, consistent directions for every child in the family than two bottles of varying concentrations with absent or vague instructions. I hope the FDA does the right thing: If safety is their main concern, the proposed changes sound like a smart step in the right direction.

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