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Kids’ Cough Medicine Recalled Over Dosing Issue

Robitussin, Dimetapp caps may not give proper dosage

November 1, 2007     Spanish

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Some children’s cough medicine is being recalled, not because of what’s in the bottle, but because of what’s on top of the bottle.

Wyeth Pharmaceutical is recalling the products because the bottle caps, used to measure dosage, don’t accurately mark the half-teaspoon level recommended for children ages 2 to 5.

Wyeth Consumer Healthcare, a division of Wyeth, announced a voluntary recall and replacement program for all U.S. retail outlets that sell several Robitussin products and Children’s Dimetapp Cold & Chest Congestion.

“This action is specific to the dosage cup and not related to the medication itself,” Wyeth said in a statement. For children age two to under six, the Company is advising consumers not to use these medicines until the replacement products with the new cup are available.

While the company says there is nothing wrong with the medicine, dosage can be critically important when administered to young children. Public health officials, including the City of Baltimore Health Department, recently asked the Food and Drug Administration to ban cough medicines for kids because overdosing can cause serious injury and even death.

Wyeth says the replacement products with the new dosage cup are expected to be available beginning in early November 2007. Packaging for the replacement products will be marked to indicate that the new dosage cup is included.

The recall and replacement program for these products does not affect other Robitussin and Dimetapp cough and cold products.

Recalled products:

• Robitussin® Cough DM
• Robitussin® Cough & Cold CF
• Robitussin® Cough & Congestion
• Robitussin® Chest Congestion
• Robitussin® Head & Chest Congestion PE
• Robitussin® Cough Sugar Free DM
• Children’s Dimetapp® Cold & Chest Congestion

Important Instructions for Parents and Caregivers

Wyeth also recommend that parents and caregivers of children age two to under six do the following:

• Do not use these medicines in children age two to under six because the dosage cup does not have a half-teaspoon mark, which is the dose on the label of these products for this age group.
• Consult their healthcare professional concerning the most appropriate way to treat cough and cold symptoms for children age two to under six.
• Call 1-800-762-4675 for more information.

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