May 14, 2004
McNeil Consumer & Specialty Pharmaceuticals is alerting consumers that one manufacturing lot of Johnson & Johnson Children's Motrin (ibuprofen) Grape Chewable Tablets may mistakenly contain Tylenol 8-Hour extended release (acetaminophen) Geltabs. Lot # JAM108 was distributed nationwide to wholesale and retail customers between February 5 and April 1, 2004. The bottles are labeled as containing 24 tablets.
The Tylenol 8-Hour product provides an adult dose of acetaminophen, and use of this adult product could provide more than the recommended dose (overdose) for children. The mislabeled bottles appear to be the result of a packaging error for this one lot. To date, two mislabeled bottles have been identified but no injuries have been reported as a result of this issue.
The two medicines are visibly different. Children's Motrin Grape Chewable Tablets are round, purple-colored, scored tablets with the letters MO and the number 50 on the tablet surface. These tablets have a non-glossy finish and a grape smell. The Tylenol 8-Hour Geltabs are hard, round, gelatin coated and shiny. The geltabs are white on one side, red on the other, with "8 Hour" printed in blue on either the red or the white side.
Consumers can identify the manufacturing lot number that is embossed on the carton end flap, and printed on the bottle label under McNeil's address as "Exp 1/06 JAM108". Anyone identifying one of the bottles included in this consumer alert should contact McNeil's Consumer Relationship Center at 1-800-962-5357.
Parents who believe their children may have taken Tylenol 8-Hour Geltabs, believing them to be Children's Motrin Grape Chewable Tablets, should contact their health care provider or a poison control center immediately.
If you think your child may have taken an adult dose of acetaminophen, you should call the National Poison Control Center Hotline at 1-800-222-1222.
For more information on this consumer alert, or to report an adverse event, call McNeil's Consumer Relationship Center at 1-800-962-5357.
