You are likely one of the millions of parents who turn to oral over-the-counter, or OTC, cough and cold medicines when treating your children’s cough and cold symptoms. As such, you may have some questions about new labeling on oral OTC cough and cold medicines for children. Here’s what you need to know:
Are children’s oral OTC cough and cold medicines safe? Yes. Children's OTC oral cough and cold medicines are safe and effective when given as directed. Although problems with these medicines are very rare and mostly related to incorrect dosing and curious, young children getting into medicines, manufacturers are voluntarily changing labels for children under age 4. Adult cough and cold medicines are not part of this label update.
Will these still be available for use in children?
Yes, these OTC oral pediatric cough and cold medicines are still available to help relieve children's cough and cold symptoms. While new labels will start appearing on these medicines during the 2008-2009 cough and cold season, you may continue to give them to your children age 4 and older.
What will the new labels say?
The medications themselves will be the same medicines you've relied on for years when caring for your children, but soon they will have new labels that advise parents and caregivers not to use them for children under age 4. Current dosing instructions for children, age 4 and older, will not change. In addition, oral OTC cough and cold medicines containing antihistamines (which are clearly labeled with that word in the "uses" section of the Drug Facts label) will carry a new warning: Do not use to sedate or make a child sleepy.
Why are the labels being changed?
These changes are being made in consultation with FDA out of an abundance of caution to help address rare adverse events related to the misuse of these medicines. While the medicines themselves are safe and effective when used as directed, rare adverse events have occurred in young children from misuse and accidental ingestion. These label changes are part of an overall effort by medicine makers to encourage appropriate dosing practices.
What should I do if my child has a cold or cough now?
Parents should always follow the label directions on the Drug Facts label. To address the needs of children of ages for which directions are not included on the product label, you should ask a doctor for treatment advice. As always, you should contact a doctor or other healthcare professional with any questions.
What do I need to know as a parent?
The following tips will help you know how, when, and when not to give OTC oral cough and cold medicines to a child.
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Always read and follow medicine labels exactly and use the measuring device that comes with the medicine.
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Do not give a medicine only intended for adults to a child.
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Only give the medicine that treats your child’s specific symptoms.
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Never give two medicines at the same time that contain the same active ingredient.
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Do not use oral cough and cold medicines for children under age 4.
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Never use an OTC medicine to sedate or make a child sleepy.
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Never give aspirin-containing products to a child for cold or flu symptoms unless told to do so by a doctor.
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If your child develops any side effects or reactions that concern you, stop giving the OTC medicine and contact a doctor immediately.
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Keep all medicines out of your child’s reach and sight.
- Talk to a doctor, pharmacist, or other healthcare provider if you have any questions.
Talk to a doctor, pharmacist, or other healthcare provider if you have any questions. For more information on the background on oral cough and cold medicines for children, click here.