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Use of Over-the-Counter (OTC) Cough and Cold Products in Infants and Children - Full Version

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On January 17, 2008 the Food and Drug Administration issued a public health advisory titled: FDA Recommends that Over-the-Counter Cough and Cold Products not be used for Children under Two-Years-of-Age. I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research.

FDA has completed its review of information about the safety of over-the-counter, also known as OTC, cough and cold medicines in infants and children under two- years-of age. FDA is recommending that these drugs not be used to treat infants and children under two-years-of-age because serious and potentially life-threatening side effects can occur.

FDA's recommendation is based on both the review of the information we received about serious side effects in children and the discussion and recommendations made at the public advisory committee meeting held on October 18th and 19th 2007, at which this issue was discussed. FDA strongly supports the actions taken by many pharmaceutical manufacturers to voluntarily withdraw cough and cold medicines that were being sold for use in this age group.

FDA has not completed its review of information about the safety of OTC cough and cold medicines in children two through eleven-years-of-age. We are aware of reports of serious side effects from cough and cold medicines in children two- years-of age and older. FDA is committed to completing its comprehensive and thorough review of the safety of OTC cough and cold medicines in children two- years-of age and older as quickly as possible and expects to communicate our recommendations to the public in the near future.

Pending completion of FDA's ongoing review, if parents and caregivers use OTC cough and cold medicines in children two- years-of age and older, FDA recommends:

  • Checking the "active ingredients" section of the DRUG FACTS label. This will help you understand what "active ingredients" are in the medicine and what symptoms each active ingredient is intended to treat. Cough and cold medicines often have more than one "active ingredient", such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a combination pain reliever and fever reducer.

  • Being very careful if you are giving more than one OTC cough and cold medicine to a child. Many OTC cough and cold medicines have more than one "active ingredient." If you use two medicines that have the same or similar "active ingredients" a child could get too much of an ingredient which may hurt your child. For example, do not give a child more than one medicine that has an antihistamine.

  • Carefully following the directions in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it.

  • Only using the measuring spoons or cups that come with the medicine or those made specifically for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines.

  • Choosing OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of the reach of children.

  • Understanding that using OTC cough and cold medicines are intended only to treat your child's symptoms. OTC cough and cold medicines do not treat the cause of the symptoms or shorten the length of time your child is sick. They only relieve symptoms and make your child feel more comfortable.

  • Not using these products to sedate your child or to make children sleepy.

  • Calling a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children two- years-of-age and older.


We urge parents, caregivers and healthcare providers to report side effects that may be associated with the use of OTC cough and cold medicines in children two-years-of-age and older to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash C-D-E-R.

Date created: January 18, 2008


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