Questions and Answers
Pediatric Cough Cold Medicine Voluntary Withdrawal
What products are being voluntarily withdrawn from the market?
Why is McNeil voluntarily withdrawing these products from the market?
What is the meeting with the FDA in October about?
What is McNeil's perspective on the safety and efficacy of these products?
Are OTC cough and cold medicines safe to use in my patients under 2 years of age?
Do these changes apply to single-ingredient analgesic/antipyretic products?
What should I tell my patients if they have the affected products in their home?
Can my patients get a refund for this product?
What are the goals of your consumer education initiative and when will this begin?
What should I do if I have questions?
A. McNeil Consumer Healthcare has decided to voluntarily withdraw the following OTC pediatric cough and cold medicines from the market:
- Concentrated Tylenol® Infants' Drops Plus Cold
- Concentrated Tylenol® Infants' Drops Plus Cold & Cough
- PediaCare® Infant Dropper Decongestant
- PediaCare® Infant Dropper Long-Acting Cough
- PediaCare® Infant Drops Decongestant (containing pseudoephedrine)
- PediaCare® Infant Dropper Decongestant & Cough
- PediaCare® Infant Drops Decongestant & Cough (containing pseudoephedrine)
While most parents use cough and cold medicines appropriately and follow the dosing directions, we've become aware of rare instances of misuse leading to overdose, especially in children under two years of age. We are committed to the safety and well- being of children and in an effort to reduce overdose, we have decided to discontinue these products. We believe that the withdrawal of these products will further encourage contact between you and your patients.
In addition, we are committed to the continued study of these medicines in children and will continue to work with the FDA and pediatric experts to ensure that parents and doctors have appropriate treatment choices for their children. We will also be initiating additional educational campaigns to build awareness for parents and caregivers about how to appropriately use cough and cold medicines in children. We are encouraging caregivers with specific concerns regarding the use of pediatric cough and cold medicines to consult their healthcare provider. To help support you in educating parents and caregivers, you can also turn to our website www.TylenolProfessional.com for additional tools and information.
Q. What products are being voluntarily withdrawn from the market?
A. This voluntary product withdrawal involves the following products:
- Concentrated Tylenol® Infants' Drops Plus Cold
- Concentrated Tylenol® Infants' Drops Plus Cold & Cough
- PediaCare® Infant Dropper Decongestant
- PediaCare® Infant Dropper Long-Acting Cough
- PediaCare® Infant Drops Decongestant (containing pseudoephedrine)
- PediaCare® Infant Dropper Decongestant & Cough
- PediaCare® Infant Drops Decongestant & Cough (containing pseudoephedrine)
A. No, this is not a product recall. While most parents use cough and cold medicines appropriately and follow the dosing directions, we've become aware of rare instances of misuse leading to overdose, especially in children under 2 years of age. So we have decided to discontinue the use of our Concentrated Tylenol® Infants' Drops Plus Cold and Concentrated Tylenol® Infants' Drops Plus Cold & Cough, and PediaCare® Infant dropper products. As such, we are voluntarily withdrawing these products from the market.
Q. Why is McNeil voluntarily withdrawing these products from the market?
A. While most parents use cough and cold medicines appropriately and follow the dosing directions, we've become aware of rare instances of misuse leading to overdose, especially in children under 2 years of age. So we have decided to discontinue the use of our Concentrated Tylenol® Infants' Drops Plus Cold and Concentrated Tylenol® Infants' Drops Plus Cold & Cough, and PediaCare® Infant dropper products. As such, we are voluntarily withdrawing these products from the market.
A. No. When used as directed, these products are safe and effective and remain available for parents and caregivers.
This voluntary withdrawal does not include:
- Children's Tylenol® cough and cold medicines for children over age two
- PediaCare® children's cough and cold medicines for children over age two
- Infants' and Children's Tylenol® pain relievers and fever reducers
- Infants' and Children's Motrin® pain relievers and fever reducers
Q. What is the meeting with the FDA in October about?
A. An advisory committee to the U.S. Food and Drug Administration will meet October 18th and 19th to discuss OTC pediatric cough and cold medicines. McNeil Consumer Healthcare, in support of the Consumer Healthcare Products Association (CHPA) has provided the FDA with new recommendations on the use of OTC cough and cold medications in children. McNeil Consumer Healthcare is committed to working with the FDA and pediatric experts to ensure that parents and doctors have appropriate treatment choices for their children through ongoing educational and scientific experts.
Q. What is McNeil's perspective on the safety and efficacy of these products?
A. Used as directed, these cough and cold medicines are generally recognized as safe and effective.
While most parents use cough and cold medicines appropriately and follow the dosing directions, we've become aware of rare instances of misuse leading to overdose, particularly in children under 2 years of age. So we have decided to discontinue the use of our Concentrated Tylenol® Infants' Drops Plus Cold and Concentrated Tylenol® Infants' Drops Plus Cold & Cough, and PediaCare® Infant dropper products. As such, we are voluntarily withdrawing these products from the market.
Q. Are OTC cough and cold medicines safe to use in my patients under 2 years of age?
A. Most parents use these cough and cold medicines appropriately. However, our assessment of the use of these medicines reveals rare instances of misuse leading to overdose, especially in children under the age of 2 years. McNeil Consumer Healthcare has decided to voluntarily withdraw the following OTC pediatric cough and cold medicine from the market:
- Concentrated Tylenol® Infants' Drops Plus Cold
- Concentrated Tylenol® Infants' Drops Plus Cold & Cough
- PediaCare® Infant Dropper Decongestant
- PediaCare® Infant Dropper Long-Acting Cough
- PediaCare® Infant Drops Decongestant (containing pseudoephedrine)
- PediaCare® Infant Dropper Decongestant & Cough
- PediaCare® Infant Drops Decongestant & Cough (containing pseudoephedrine)
If parents or caregivers have one of the medicines that we are voluntarily withdrawing from the market, we ask that you instruct them to discontinue use in children under 2 years. We will make coupons available to your patients at www.Tylenol.com.
Q. Do these changes apply to single-ingredient analgesic/antipyretic products?
A. When used as directed, these products are safe and effective and remain available for use by parents and caregivers.
This voluntary withdrawal does not include our single ingredient pain relievers and fever reducers such as:
- Concentrated Tylenol® Infants' Drops
- Children's Tylenol®
- Concentrated Motrin® Infants' Drops
- Children's Motrin®
Q. What should I tell my patients if they have the affected products in their home?
A. . If parents or caregivers have one of the medicines that we are voluntarily withdrawing from the market, we ask that you instruct them to discontinue use in children under 2 years. We will make coupons available to your patients at www.Tylenol.com.
Q. Can my patients get a refund for this product?
A. Yes, and we will also offer patients coupons toward the future purchase of a McNeil Consumer Healthcare product. Consumers can contact our Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish).
A. The American Academy of Pediatrics recommends these non-medicinal measures to help relieve symptoms of a common cold:
- Saline nose drops may help thin mucus and a suction bulb can be used to remove mucus clogging the child's nose
- A cool-mist humidifier in the child's bedroom may help clear a stuffy nose
- Plenty of clear liquids, such as juice or water, should be given to the child to avoid dehydration
- Fever may be treated with acetaminophen for babies 6 months or younger; either acetaminophen or ibuprofen for children older than 6 months
Q. What are the goals of your consumer education initiative and when will this begin?
A. McNeil has a longstanding commitment to educating patients about the responsible use of over-the-counter medicines. Our overarching goal is to educate parents and other caregivers on the appropriate use of OTC cough and cold medicines in children—and the proper, safe use of all OTC products. Specifically, the campaign will encourage parents and caregivers to:
- Read and follow the label instructions on OTC medicines
- Use the dosing device that comes with a specific product
- Keep all medicines out of the reach of children
- Not administer two products containing the same active ingredients at the same time
- Not administer adult medicines to children
- Not use cough and cold or allergy medicines to sedate children
Q. What should I do if I have questions?
A. You can contact the medical staff of McNeil Consumer Healthcare a number of ways. First, you should turn to www.TylenolProfessional.com. This Web site is a resource for healthcare professionals and allows you to email us questions. You can also call our McNeil Consumer Healthcare Medical Affairs Department at 1-877-895-3665. Finally, you can write to the following address:
McNeil Consumer Healthcare
Medical Affairs Department
7050 Camp Hill Road
Fort Washington, PA 19034