WARNING - INFANTS & CHILDRENS PRODUCTS RECALL

Postmarket Drug Safety Information for Patients and Providers > Questions and
answers on voluntary recall of certain liquid infant’s and children’s Tylenol,
Motrin, Zyrtec, and Benadryl products
      
Final Report Drug Safety Information for Healthcare Professionals- Questions and
answers on voluntary recall of certain liquid infant’s and children’s Tylenol,
Motrin, Zyrtec, and Benadryl products
 
What products are affected by this recall?
The products include certain liquid infant’s and children’s Tylenol Motrin,
Zyrtec, and Benadryl products. For a complete list of recalled products, please
see http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc
Why were these products recalled?
McNeil Consumer Healthcare is initiating this voluntary recall because some of
these products may not meet required quality standards. As a precautionary
measure, parents and caregivers should not administer these products to their
children.  Some of the products included in the recall may contain a higher
concentration of active ingredient than specified; others contain inactive
ingredients that may not meet internal testing requirements; and others may
contain tiny particles. While the potential for serious medical events is
remote, FDA advises consumers who have purchased these recalled products to
discontinue use.
 
What can I use instead of the recalled products?
There are a number of other products on the market that are intended for use in
infants and children. FDA recommends that you check the labeling of these
products. If you have any questions, you should discuss this with your
pharmacist or other healthcare professional. FDA does not anticipate that there
will be a shortage of alternative products.
 
Can I give my child adult strength Tylenol or Motrin products that are not being
recalled?
No.  Consumers should not give drug products to infants and children that are
not intended for those age groups. This could result in serious harm.
 
What should I do if I have some of the medication at home?
FDA recommends that consumers stop using these products. For further
instructions, see McNeil’s website at:
http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc.
 
I gave my child some of the medication. What do I do? Is my child at risk?
According to the information the FDA has received at this time, the potential
for serious medical problems is remote. If your child exhibits any unexpected
symptoms after use of any of the recalled products, contact your healthcare
provider.
 
If I think my child may be having an adverse reaction to one of the products
involved in this recall, who should I notify?
Adverse reactions or quality problems experienced with the use of these products
may be reported to FDA's MedWatch Adverse Event Reporting program either online,
by regular mail, or by fax, using the contact information at the bottom of this
sheet. The agency asks health care professionals and consumers to report any
adverse reactions to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by
mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the
MedWatch website at www.fda.gov/medwatch.
     -Related InformationMcNeil Consumer Healthcare Announces Voluntary Recall
  of Certain OTC Infants’ and Children’s Products 
  McNeil Recalls Infant and Children’s Liquid Products Including Tylenol and
  Motrin