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Cough & Cold Medicine Advisory & Tips for Parents

U.S. Food & Drug Administration |23, October 2007


August 15, 2007 - FDA announced today that, in October, the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age. In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products.

Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the "Drug Facts" box on the package label.

What should parents know about using cough and cold products in children?

* Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider.

* Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called "pediatric" use).

* Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a healthcare provider.

* If other medicines (over-the-counter or prescription) are being given to a child, the child's healthcare provider should review and approve their combined use.

* Read all of the information in the "Drug Facts" box on the package label so that you know the active ingredients and the warnings.

* Follow the directions in the "Drug Facts" box. Do not give a child medicine more often or in greater amounts than is stated on the package.

* Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger.

* For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine formulation and that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.

* If a measuring device is not included with the product, parents should purchase one at the pharmacy. Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the "Drug Facts" box on the package label, or is recommended by the child's health care provider.

* If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device (dropper, dosing cup or dosing spoon), DO NOT USE the medicine. Consult your healthcare provider if you have questions or are confused.

* Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability. They do not cure the common cold. Children get better with time.

* If a child's condition worsens or does not improve, stop using the product and immediately take the child to a health care provider for evaluation.

Related Articles

Cold and Flu Survival Guide for Parents

Decoding the Cough in Babies & Toddlers

9 Clues - Allergies or the Common Cold?

Mom's 2014 Cold and Flu Survival Guide

Treating Baby's Cold or Flu at Home Safely


Showing 1 - 10 out of 11 Comments
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Yvonne Jan 25, 2018 02:35:46 PM ET

My 7weeks baby has got a tough cough. Can I use any medicine or what can I do?

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Shaya Jan 28, 2017 05:30:25 PM ET

Hello My 8 month old daughter was coughing for the past few days. I tooke her to the doctor. They wrote this medicine soolan and told me to give her 2 mins Have u guys tried this medicine before and how is it ? Help please??

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madhura Dec 18, 2016 01:30:48 AM ET

Hi, my 9month old baby is suffering from cough. As recurrence of cough has become more often, so this time his doctor has given him one antibiotic. But I am a little bit worried. Is it safe to take antibiotics?

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veev Jul 21, 2014 12:31:08 AM ET

My 5 months old son has been having a cough since 1 week. I give him vitC syrup 2 times daily but no improvement. Fast healing remedy please?

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lupe Nov 4, 2012 03:54:05 AM ET

My 21month old got the flu shot aday ago and now he has a cold, red eyes n cheecks fever runny nose and cough wut kind of medicine should i give him plz help

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Laura Jan 10, 2012 08:28:52 AM ET

I have a 16 month old son an he is currently trying to get over a cold. He's got a stuffy nose and a constant dry cough. He is so uncomfortable at night time that he cannot sleep, which means no sleep for me either! Since he can't take cough & cold medicines home remedies are pretty much his only hope in getting over this. When he gets a cough or seems to be congested I give him a nice warm bath and then I rub Vicks Vapor Rub for baby's on his chest, the back of his neck and the bottoms of his feet. This usually helps him to breath better and helps to make him feel a little more comfortable. I then put footy pajamas on him to hold in the vapors from the vicks. I also use a cold mist vaporizer and run it at night time. I found that its best to turn it on about an hour before bedtime that way it's had time to build up some moisture in his room. Another important thing is to push fluids! Hope this info will help!

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laurie Jan 2, 2012 10:55:59 PM ET

My 8 month old son struggled with terrible coughing fits, especially at night, from colds. It got so bad one night, that I took him to the ER. I was advised to give him just under a teaspoon of children's benedryl, along with humidifying and vapor rub. Elevating the child's head while they sleep provides relief also. These methods help, but usually the cold will have to run it's course :(

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susan Oct 17, 2011 01:02:01 PM ET

Hi All, MY 19 months baby boy suffering with cold from past 20 days.taking him to doctor and using medicines hasnt worked out for him .please suggest any home remedies which will work out

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jagpal Jan 5, 2011 04:12:22 AM ET

Our 2.5 month old baby have cough for 4 days .what medicine can i use

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Liz = grandma Dec 21, 2009 05:53:39 PM ET

My 13month grandson has a cold and cough. What can be done to help him

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