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Important Children's Motrin Recall

Children's Motrin Recall

========================

McNeil Consumer & Specialty Pharmaceuticals Announces Nationwide Consumer

Alert of Children's Motrin Grape Chewable Tablets

Contact: Kathy Fallon

Ami Schmitz-Levine

FOR IMMEDIATE RELEASE -- Fort Washington, PA -- May 12, 2004 -- McNeil

Consumer & Specialty Pharmaceuticals is alerting consumers that one manufact

uring

lot (Lot # JAM108, exp 1/06) of Children's Motrin (ibuprofen) Grape Chewable

Tablets may mistakenly contain Tylenol 8-HourĀ® extended release (acetamino

phen)

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. In the interest of

patient health and safety, McNeil, in consultation with the U.S. Food and Dr

ug

Administration, is taking the precaution of alerting consumers nationwide

about this issue to help them identify the potentially affected product. McN

eil

has also alerted retailers nationwide.

The two medicines are visibly different. Children's Motrin Grape Chewable

Tablets are round, purple-colored, scored tablets with the letters MO and th

e

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 " pr

inted

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 consume

r

alert should contact McNeil's Consumer Relationship Center at 1-

..

Parents who believe their children may have taken Tylenol 8-Hour Geltabs,

believing them to be Children's Motrin Grape Chewable Tablets, should contac

t

their health care provider or a poison control center immediately.

For more information on this consumer alert, or to report an adverse event,

please call McNeil's Consumer Relationship Center at 1-.

McNeil continues to be committed to the integrity of its products and the

health and safety of the patients who use its product.

For more information:

<A

HREF= " http://newsletters.keepkidshealthy.com/cgi-bin/knowwhat.cgi?l=pedi

atrics.about.com/b/a/085809.htm " >Children's Motrin Recall</A>

<A HREF= " http://newsletters.keepkidshealthy.com/cgi-bin/knowwhat.cgi " >more

Know What topics</A>

<A HREF= " http://www.keepkidshealthy.com " >Visit keepkidshealthy.com</A>

********************************************************************************\

***************

Sincerely,

Corby, President

Autism Solution Center, Inc.

8567 Macon Rd., Suite B

Cordova, TN 38018

(901)758-8288

laura@...

www.autismsolutioncenter.org

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