Dear Valued Retailers and Pharmacists,
As you may be aware, following consultations with Health Canada, McNeil Consumer Healthcare, a division of Johnson and Johnson Inc., will join other leading manufacturers of over-the-counter medicines to transition labeling on all oral pediatric cough and cold medicines to state “do not use in children under age six.”
The transition to McNeil Consumer Healthcare’s relabeled medicines, which will also include dosing devices and child-resistant packaging for all products, will be completed by fall 2009. Health Canada states that medicines with the current labeling will remain on store shelves during the current cough and cold season. It is important for you to know that parents can continue to use these medicines with confidence in children age six and older. As with all medicines, parents and caregivers should always follow the directions on the label.
The following pediatric cough and cold medicines should not be used in children under six years of age:
- BENYLIN DM-D® for Children Cough & Cold
- BENYLIN DM® for Children Dry Cough
- BENYLIN DM® for Children Dry Cough Bedtime 12 hr.
- BENYLIN® for Children All-In-One Cold & Fever
- BENYLIN® for Children All-In-One Cold & Fever Nightime
- Children's TYLENOL® Cold
- Children's TYLENOL® Cold & Cough
- Children's TYLENOL® Cold & Cough Nighttime
- Children's TYLENOL® Cough & Runny Nose
- Children's TYLENOL® Decongestant
- Children's TYLENOL® Cold & Cough (Cold DM)
- Junior Strength TYLENOL® Cold & Cough (Cold DM)
Research shows that reports of adverse events are rare in children and primarily caused when medicines are misused. McNeil Consumer Healthcare has always encouraged the appropriate use of pediatric cough and cold medicines and we look forward to working together with you, and Health Canada, to ensure that parents and caregivers have the necessary support to properly use these medicines to care for their children.
To provide you with the most current information to make appropriate treatment choices we are providing you with the following press release dated December 18, 2008. Should you have further questions please contact the McNeil Consumer Healthcare Information Centre at 1-800-265-7323 or visit www.tylenol.ca, www.benylin.ca, or www.jnjcanada.com.
We greatly appreciate your ongoing support.
Respectfully,
Bill Murphy
Vice President OTC, Latin America and Canada
McNeil Consumer Healthcare
MEDIA INQUIRIES:
Shelley Kohut
t: 514-251-5548
c: 514-917-9997
SKohut@its.jnj.com
Scott Evans
t: 416-979-1120 ext. 325
c: 416-473-6791
scott.evans@edelman.com
McNEIL CONSUMER HEALTHCARE SUPPORTS EFFORTS TO ENCOURAGE APPROPRIATE USE OF CHILDREN'S COUGH AND COLD MEDICINES IN CANADA
MARKHAM, ON (December 18, 2008) – In cooperation with Health Canada, McNeil Consumer Healthcare, a division of Johnson & Johnson Inc., and other leading manufacturers of over-the-counter medicines today announced efforts to help further encourage the continued appropriate use of cough and cold medicines in Canadian children.
After consulting with Health Canada, McNeil Consumer Healthcare and other manufacturers will begin transitioning to labels on children’s cough and cold medicines that will state “do not use in children under age six.” Dosing devices and child-resistant packaging will also be included as part of relabeled medicines.
Health Canada states that medicines with the current labeling will remain on store shelves during the current cough and cold season. The transition of McNeil Consumer Healthcare’s re-labeled medicines (see complete list of affected medicines below) should be completed by fall 2009. In the meantime, parents can continue to use these medicines with confidence in children age six and older. As with all medicines, parents and caregivers should always follow the directions on the label.
“Families have relied on cough and cold medicines to comfort their children for more than 30 years,” said Bill Murphy, Vice President OTC, Latin America and Canada, McNeil Consumer Healthcare. “McNeil Consumer Healthcare has always encouraged the appropriate use of these medicines and these actions will further support parents and caregivers as they care for children with colds.”
Children’s cough and cold medicines remain safe and effective for use in children age six and older, when used as directed. Research shows that reports of adverse events are rare in children and primarily caused when medicines are misused.
The label changes do not apply to those pain reliever/fever reducers containing a single active ingredient such as INFANTS’ and CHILDREN’S TYLENOL® (acetaminophen) and INFANTS’ and CHILDREN’S MOTRIN® (ibuprofen).
The following children’s cough and cold medicines should not be used in children under six years of age:
- BENYLIN DM-D® for Children Cough & Cold
- BENYLIN DM® for Children Dry Cough
- BENYLIN DM® for Children Dry Cough Bedtime 12 hr.
- BENYLIN® for Children All-In-One Cold & Fever
- BENYLIN® for Children All-In-One Cold & Fever Nightime
- Children's TYLENOL® Cold
- Children's TYLENOL® Cold & Cough
- Children's TYLENOL® Cold & Cough Nighttime
- Children's TYLENOL® Cough & Runny Nose
- Children's TYLENOL® Decongestant
- Children's TYLENOL® Cold & Cough (Cold DM)
- Junior Strength TYLENOL® Cold & Cough (Cold DM)
Consumers, retailers or health care professionals who have questions or concerns about the medicines described in this communication should contact the McNeil Consumer Healthcare Information Centre at 1-800-265-7323 or visit www.tylenol.ca, www.benylin.ca, or www.jnjcanada.com.
McNeil Consumer Healthcare, a division of Johnson & Johnson Inc., markets a broad range of well-known and trusted over-the-counter (OTC) products around the globe. McNeil Consumer Healthcare in Canada markets products in the adult and pediatric pain relief, allergy, gastro-intestinal and nicotine-replacement categories under the brand names TYLENOL®, MOTRIN ®, BENYLIN®, BENADRYL®, REACTINE®, IMODIUM®, ROLAIDS®, NICORETTE® and NICODERM®.
Press Release