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Q & A on Tylenol/Motrin/Zyrtec Recall

Questions and Answers

Which products contain a higher concentration of active
ingredient?

Only one product, concentrated TYLENOL® Infants’ Drops 1 oz. Cherry Dye
Free (NDC: 50580-167-01), was identified as potentially containing a
higher concentration of active ingredient than specified on the label.

Are any recalled products contaminated with bacteria?
To our knowledge, no bacterially contaminated components were used in
the final manufacture of any of our recently recalled products. Also,
testing done to date has not found bacteria in any components used to
make finished products or in the finished products themselves.

What kind of particles are in the recalled products?
Some of the recalled products may contain solidified product ingredients
or manufacturing residue, such as tiny metal specks. The number, shape,
composition and size of the particles makes the potential risk of
serious medical events remote. Patients should discontinue use of all
recalled products.

Was this recall conducted due to reports of adverse events?
This recall is not being undertaken on the basis of adverse medical
events. However, as a precautionary measure, patients should discontinue
use of these products. Any adverse reactions may be reported 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.

When will these products be available again?
The company is continuing to conduct a comprehensive quality assessment
across its manufacturing operations. Only after this assessment is
complete and corrective actions are identified and implemented will new
manufacturing be initiated and products be available from the plant
where the recalled products were made.

Can patients get a refund or coupon?
McNeil is offering two options for patients who have purchased products
affected by this recall. Patients can receive either a refund for the
average retail price of the product or a coupon for a free
replacement(s) when the product becomes available again. Patients
looking for information about a refund or coupon for recalled product
can call the company at 1-888-222-6036.

What single-ingredient acetaminophen-containing medicines are
available for pediatric patients?

Pediatric acetaminophen liquid products are available from other
manufacturers for use in infants and children. In addition, children
between the ages of 2 and 5 years old can use Children’s TYLENOL®
(acetaminophen) Meltaways. Children between the ages of 6 and 11 years
old can use Junior Strength TYLENOL® (acetaminophen) Meltaways. Remember
to counsel parents and caregivers to never give drug products to
infants and children that are not intended for those age groups as this
could result in serious harm.

What single-ingredient ibuprofen-containing medicines are
available for pediatric patients?

Pediatric ibuprofen liquid products are available from other
manufacturers for use in infants and children. In addition, children
between the ages of 2 and 11 years old can use Junior Strength MOTRIN®
(ibuprofen) Chewables. Children between the ages of 6 and 11 years old
can use Junior Strength MOTRIN® (ibuprofen) swallowable Caplets.
Remember to counsel parents and caregivers to never give drug products
to infants and children that are not intended for those age groups as
this could result in serious harm.

What single-ingredient cetirizine-containing medicines are
available for pediatric patients?

Pediatric cetirizine liquid products are available from other
manufacturers for use in children. Children 6 years old and older, who
can swallow pills, can use regular ZYRTEC®. Remember to counsel parents
and caregivers never to give drug products to infants and children that
are not intended for those age groups as this could result in serious
harm.

Are any single-ingredient BENADRYL® (diphenhydramine)
products available for pediatric patients?

Some single-ingredient pediatric liquid BENADRYL® (diphenhydramine)
medicines remain on the market. In addition, for children ages 6 years
old and over, you can use Children’s BENADRYL® Perfect Measure which is a
unit-dose liquid product. For children 6 years old and over, Children’s
BENADRYL® FastMelts are also available. Remember to counsel parents and
caregivers to never give drug products to infants and children that are
not intended for those age groups as this could result in serious harm.

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