FORT WASHINGTON, Pa., Oct. 7 As part of the industry'scontinuing dialogue with the U.S. Food and Drug Administration (FDA), McNeilConsumer Healthcare, a division of McNeil-PPC, Inc., announced today newvoluntary actions that will help further encourage safe and appropriate use ofchildren's cough and cold medicines.
After consulting with the FDA, McNeil Consumer Healthcare and othermanufacturers will transition the labeling on children's cough and coldmedicines to state "do not use" in children under age 4 years; and the labelson children's medicines containing a monograph antihistamine will also featurea warning, "do not use to make a child sleepy." Pediatric cough and coldmedicines remain safe and effective when used as directed; and because reportsof adverse events are very rare, and mostly associated with misuse oraccidental ingestion in younger children, the FDA supports the continued useof these medicines for symptom relief in children age 4 years and older.
As with other OTC labeling changes in the past, FDA has indicated it doesnot believe this labeling change warrants the removal of products with the oldlabeling from store shelves during this time of transition. The transition ofre-labeled McNeil Consumer Healthcare medicines should be complete before theend of the year. (Please see a complete list of affected McNeil ConsumerHealthcare medicines below)
"Over-the-counter pediatric cough and cold medicines have helped familiesprovide comfort for their children for more than 30 years," said AshleyMcEvoy, President, McNeil Consumer Healthcare. "McNeil Consumer Healthcarehas always encouraged the appropriate use of these medicines. Our actionstoday include label changes, educational initiatives for parents, caregiversand healthcare professionals as well as science and surveillance commitments."
McNeil Consumer Healthcare's pediatric cough and cold medicines willcontinue to include dosing information for children age 4 years and older.The label changes do not apply to single-ingredient pain reliever/feverreducers such as INFANTS' and CHILDREN'S TYLENOL(R) (acetaminophen) andINFANTS' and CHILDREN'S MOTRIN(R) (ibuprofen) and also do not apply to single-ingredient allergy medicines such as CHILDREN'S ZYRTEC(R) (cetirizine) andCHILDREN'S BENADRYL(R) (diphenhydramine).
The following cough and cold medicines should no longer be used inchildren under age 4 years:
The following children's medicines that contain an antihistamine will bere-labeled to feature a warning; "do not use to make a child sleepy":
For More Information:
Consumers or retailers who have questions or concerns about the medicinesdescribed in this communication should contact the Johnson & Johnson ConsumerCare Center at 1-888-222-0082 (English and Spanish) or visit www.tylenol.com.
The American Academy of Family Physicians offers the followingrecommendations for caring for a child with a cough or cold:
McNeil Consumer Healthcare Division of McNeil-PPC, Inc. markets a broadrange of well-known and trusted over-the-counter (OTC) products around theglobe. McNeil Consumer Healthcare is most widely recognized for the completeline of TYLENOL(R) (acetaminophen) products, the leading pain reliever brandin the adult and pediatric categories. The TYLENOL(R) product line consists ofhundreds of products across a variety of pain categories including: arthritispain, pain with accompanying sleeplessness and pain with cough, colds andallergies. Other McNeil Consumer Healthcare brands include BENADRYL(R) allergymedicines; IMODIUM(R) A-D anti-diarrheal; MOTRIN(R) IB; PediaCare(R) upperrespiratory medicines for children; ROLAIDS(R) antacid products; ST. JOSEPH(R)Adult Regimen Aspirin; SUDAFED(R) and SUDAFED PE(R) nasal decongestants; andZYRTEC(R) over-the-counter antihistamines for adults and children.1. Children's TYLENOL(R) Plus Multi-Symptom Cold 2. Children's TYLENOL(R) Plus Cold 3. Children's TYLENOL(R) Plus Cough & Sore Throat 4. Children's TYLENOL(R) Plus Cough & Runny Nose 5. Children's TYLENOL(R) Plus Flu 6. Children's TYLENOL(R) Plus Cold & Allergy 7. Children's SUDAFED(R) Nasal Decongestant 8. Children's SUDAFED(R) PE Nasal Decongestant 9. Children's SUDAFED(R) PE Cold & Cough 10. PEDIACARE(R) Multi-Symptom Cold 11. PEDIACARE(R) Long-Acting Cough 12. PEDIACARE(R) Decongestant 13. PEDIACARE(R) NightRest Multi-Symptom Cold 14. PEDIACARE(R) NightTime Cough 15. Children's BENADRYL(R) D Allergy & Sinus
SOURCE McNeil Consumer Healthcare