FDA May Change Labeling for Children’s Medicines

Currently, if you have an infant or a child under the age of two who is sick and needs a dose of a fever and pain relief medication like Infant’s Tylenol, you may not know how much to give.  The label on these products directs you to call a doctor for dosage amounts.

Next week the FDA will meet to consider changing these labels so that parents and caregivers will know a proper dosage amount for infants.  They will also consider requiring weight-based dosing instructions alongside age-based instructions on packaging.

The lack of dosage instructions for infants has been an FDA requirement since the 1950s. The purpose behind it was to nudge people to seek medical advice for their infants. However, family doctors are not as available by phone as they were in the 1950s; and the lack of information on these medicines causes stress and overdosing hazards.

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