Acetaminophen Anecdotes #3

Children are our most valuable asset; therefore, it is good to keep safety in mind when they need to take medications. Last month, the FDA released new recommendations for the manufacturers of pediatric products containing acetaminophen. Here's a quick look at what is on the table:

All acetaminophen containing products are now supposed to contain the following statement:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

More than [insert maximum number of daily dosage units] in24 hours, which is the maximum daily amount [optional: "for this product"]

With other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product.

Here are some examples of additional recommendations for pediatric products:

that all products intended for use in children should have a concentration of less than 160mg per 5 mL
that the principal display panel contain information regarding the age range of intended use for the product
that any child on the label be representative of the intended patient population's age
that the dosing directions for the product be provided "only in milliliters"
that an image of the drug delivery device be included on the principal display panel
that all delivery devices be "appropriate" and standardized

Keep in mind that these recommendations are voluntary for manufacturers. Let's hope that they do all they can to keep our children safe!

Sources: RAPS.org;openclipart.org

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