J&J, generics makers to revamp children's Tylenol products

Tylenol maker Johnson & Johnson will revamp its product line for infants and children to help prevent overdoses of the pain and fever remedy. The company plans to make all children's Tylenol products at the same concentration of active ingredient to standardize dosing so that parents make fewer errors. Several generics makers that sell knock-off versions will do the same.

The drugmakers plan to voluntarily discontinue their infant drops, which carry a higher concentration of acetaminophen. Doses of the remaining strength--160 milligrams per 5 milliliter--will vary according to the child's age.

J&J, which recalled its infant and children's Tylenol products last year, says it will introduce the single concentration when it brings infant Tylenol back onto the market, the Wall Street Journal reports. That return is scheduled for the end of this year and beginning of 2012. In the meantime, Perrigo, which makes the lion's share of children's acetaminophen products sold under store brands, says its products will all be switched over by summertime. Triaminic maker Novartis says it will switch to the single potency level as well.

The FDA has been pressing acetaminophen makers to take steps to prevent overdosing, which has caused severe reactions and even death. As the WSJ points out, an FDA advisory panel persuaded companies to change the labels on their products in 2009. Another panel meets later this month to discuss dosing instructions keyed to children's weight.

- read the WSJ piece

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