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Cold, Flu, & Cough Health Center

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FDA: No Cold, Cough Medicines for Babies

FDA Rules That Over-the-Counter Cough and Cold Medicines Shouldn't Be Given to Kids Younger Than 2

Industry Responds continued...

"Safety has always been and continues to be our top priority," says CHPA President Linda Suydam, DPA.

"Today's decision by the FDA reaffirms the correct course of action taken by the leading makers of these medicines last fall," says Suydam, referring to the voluntary withdrawal of over-the-counter cough and cold drugs for infants.

The CHPA is working with retailers, doctors, and the FDA "to ensure that parents have the tools they need to safely and appropriately administer OTC oral cough and cold medicines to children over the age of two," Suydam says.

Tips for Parents of Older Kids

Speaking at today's FDA news conference, Lisa Mathis, MD, associate director of the FDA's Pediatric and Maternal Health Staff in the Office of New Drugs, reminded parents that the FDA hasn't finished reviewing cough and cold drugs for older children.

Mathis provided the following tips for parents who choose to give over-the-counter cough and cold medicines to children aged 2-11:

  • Always remember that these medications do not cure the cold. They don't shorten the time that your child has a cold, and they're only meant to help a child's symptoms.
  • Look at the active ingredients in the Drug Facts label. This will help you understand what active ingredients are in the medication and what symptoms each active ingredient is intended to treat. Cough and cold medications often have more than one active ingredient.
  • Be very careful in giving more than one over-the-counter cough and cold medication to your child. Remember that many over-the-counter cough and cold products have multiple medications in them. If you use two medications that have similar active ingredients, a child could get too much of the ingredient, which could be harmful.
  • Make sure to carefully follow the directions in the Drug Facts part of the label. These directions tell you how much medicine to give and how often to give it.
  • Only use the measuring device -- spoon, dropper, or cup -- that comes with the medication. Common household spoons come in different sizes and are not meant for measuring medicines. If you use these, you may not be giving the right dose.
  • If you have the opportunity to choose cough and cold medications with a childproof safety cap, you should do so, and store these medications out of the reach of children.

"Most importantly," Mathis says, "call your physician, pharmacist, or other health care professional if you have any questions about using these medications in children 2 years of age and older."

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