In the News: No Cold Medicine for Kids Under 4

By , SparkPeople Blogger
New over-the-counter cough and cold medicine labels will now say "do not use" in children younger than four. The voluntary change by drug manufacturers comes in response to research and recommendations by the U.S. Food and Drug Administration, which earlier this year discouraged the use of cough and cold medicine in children younger than two.

The Consumer Health Products Association said that human error was the reason for the label change, not the efficacy or safety of the medicines. "Research shows that dosing errors and accidental ingestions—not the safety of the ingredients themselves when properly dosed—are the leading causes of rare adverse events in young children," the CHPA said in a news release.

Adult cold and cough medicines are not affected by the decision, nor are prescription medications for children. The labels will be transitioned through the beginning of next year. Though medicines currently on store shelves might bear labels that recommend giving the product to small children, the consumer group and the FDA don't recommend doing so.

According to the CHPA, leading manufacturers will also include dosing devices with new products to prevent overmedication of children.

In addition, the FDA offers the following recommendations when giving cough or cold medicine to children ages 4 and older:
  • 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 pain reliever/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 specially 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 symptom(s). 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 make children sleepy.
  • Calling a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children 2 years of age and older.

What home remedies do you use (or have you used) to treat your child's cold?

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If I had children, I would read each label carefully and buy the OTC single symptom product for condition expereinced by that child. Blended "all in one" "super meds" overtreat the condition and may result in a toxic overdose. As an adult, I follow my own advice and treat each symptom seperately. If I have a headache, I take Tylenol. If my allergies flare up, I take an antihistimine. I avoid any product containing oral decongestants. Report
I ALWAYS advocate natural remedies before the use of drugs and extra chemicals. However, natural remedies can be harmful when used improperly too, especially in children. I think that pushing the age from 2 to 4 may not be as helpful as the FDA hopes. If the problem is the few parents who do not read the label or use improper measuring tools, why would they suddenly read the label now? If anything this may lead desperate parents to guess at the right dosage for their children or keep using it in the same improper way that they were before. For parents who actually read the label and chose not to give it to their sick child, they are going to be more desperate to find something else to help, such as a natural remedy. Usually this is great, but what if parents try to modify the natural remedy they use when they have a cold and it's not safe for a 3 year old? I agree with some of the other posts that if this is a problem, parents should be required to get the medication from the pharmacy and have the pharmacist or tech advise the parent on proper usage of the medication, even for children over 4 if this is such a dangerous situation. I also think that pharmacies and doctor/pediatricians offices should distribute pamphlets on effective natural remedies, what the appropriate dosage is for certain age groups, and what is contraindicated in certain ages or for other health issues the child might have. Report
Thanks for the great information, unfortunatley when my son gets sick, he is at risk for febrile seizures, so I am on 24/7 patrol for both my boys, checking their temps, giving them tylenol as soon as they have a slight fever, of course its doctor prescribed, I just dont go aorund dosing up my kids, but they have special conditions, unlike most children. I use those vicks vapor rubs and things that blow the vapor medicine into the room, and just make them soup and keep them comfortable. Report
We have always used lemonade (homemade) as a decongestant, it also helps a sore throat. Heating pads for ear aches, the usual chicken soup. Ginger ale for tummy upsets... But nothing is better than the good ol' blanket and old movies on the couch with a whole lot of rest. Report
I live in Iowa, the kids at the daycare all get sick and they get sick alot. The weather changes like crazy. When my son was one year old the doctors always told me to give him otc tylenol before his shots and when he was that age they stressed the importance of childrens tylenol if he had a fever to get it to go down, they informed me that it was very dangerous to let the fever run its course or to let them "sweat it out" for such a young child. With coffing and colds I found the best things for my son was the baby vicks vapor cream and bath, once he had croup and the only thing his doctor could do was to tell me to buy a humidifier (which I did) and it worked great. When I have another child I assume the tylenol before shots will have to be prescribed or giving by a doctor. Report
i work in a peds office. we have been telling people for a long time that you need to start with non-med home remedies first because of the possible interaction of drugs. even if you "can read labels" the general public may not know what will interact with an ingredient of another drug you may be giving your child. single ingredient medicines are best, such as guaifenesin or dextramethorphan, since you know exactly what you are giving. if you decide to use medicines, even in older kids, call the doctor for the dose. some children may be younger than 12 but still adult size (or bigger) or children could be much smaller than what should be given for their age. i have found that menthol/eucalyptis, humidifiers, nose bulbs (for children not yet able to blow their nose), lots of clear liquids, tepid baths, and rest clears up a lot of symptoms. then there is honey (for those over 1 year) for coughs and throats, or ginger for nausea. Report
I thought you already couldn't do this. They contain dexymethormine which is an amphedamine Report
My daughter is 8 months old and she just recently started getting colds. What I do for her is to give her baths, try to suction out as much as possible, motrin for infants when she has a fever and vicks vapor rub for babies. Since she's got a cold right now, I'm going to get some chicken noodle soup today as an extra measure. Otherwise, it's just lots of hugs and cuddling. Report
It's a good habit to get your kids to rest when they are unwell and that colds and coughs are normal and don't really need to be medicated. I have given my kids a tea made with sage, lemon juice and honey when they have coughs, this helps break up the phglem thus making the coughing productive. I have also used lavender oil to help them breathe easier and sleep. My kids are 21 and 19 now so something worked. I stopped having kiddies panadol in the house when my son (then 3) drank half the bottle. Report
The point is that they haven't been shown to be effective. And they could actually be harmful, particularly if not dosed correctly. Why would you put chemicals in your child unless absolutely necessary? It's beyond me why some people are so dead set upon using all kinds of OTC meds without even the advice of a physician. And actually the age should probably be raised to 6 and not just 4. Report
Its a good decision!
Some home remedies I use when my child is sick with cold/cough..they really work...
Grind cinnamon stick in honey.
Put a very little vaporub on the feet and fontanel of the child if he/she has runny nose and last but not least, add turmeric powder in your child's milk, lukewarm milk. Report
I think it is a good idea. Medicine is hard to get right dose for those with small children. Report
It sounds like common sense, but as someone else mentioned, we are an over medicated society. There's an illness, that is diagnosed and prescribed a medication that causes side effects and then more medication needs to be prescribed to deal with the side effects that in turn cause more side effects; it's a vicious cycle. Report
It's been reported that these medicines simply don't work for kids. I feel that we are an overmedicated society as a whole. Personally, I'd feel safer not giving my children these medicines. Report
Anyone who writes off OTC medications has obviously never had sinus congestion bad enough that your ears or face hurt so badly you cry, coughed hard enough to throw up, or coughed an entire sleepless night away. I have, and when those things happen, I take Robatussin or Sudafed. While I've never used Sudafed with my 3 year old, I have given her Robatussin twice. And it was the difference between her up and miserable and her asleep and happy. No, I was not just trying to get rid of her so she didn't bother me. She needed to sleep, and she couldn't. I use a syringe to measure out her medicine and read the label. And I don't need a $25 doctor visit to tell me virus need fluids and rest, and that nothign is goign to make it go away faster. Ads when things linger or symptoms are unusual, we run right in too. But we live in this world, and we get viruses. I don't see why, when there are things that can help temporarily, we can't take advantage of them. Now, they may not work for all kids, but Robatussin worked for mine. Report
My kids are grown, but I have had to care for my granddaughter when she was sick and found the labels very frustrating. I would stand in front of the shelves and read and scrutinize each and everything, but it was so difficult to read the tiny print. The dosing info was small and placed in an area that made it frustrating to find. No wonder people use things the wrong way, they just want something simple when they are needing to use it. It seems to me that one of the first things on the label used to be the dosage, now it is almost hidden among ALL the warnings, active and inactive ingredients, things to use it for and bigger section of what not to use it for. They tell you to stop use and see the doctor even before they tell you how to use it! It would be nice if there was a sticker in the box that was in readable print that could be placed on the medication once you get it home to remind of proper dosing amounts. (Many times the need to use these things arise in the middle of the night and we just want to be able to see the proper amount to use quickly to help that little one feel better.)
I also think there are too many multi symptom things out there and that poses a problem of over medicating. Report
We live in Iowa where the weather goes from 50* to 80* within a span of a few hours. EVERYONE gets colds here.

My three-year-old daughter will continue taking OTC for her symptoms, same as I do. However, I actually read the instructions, follow the dosage by her WEIGHT, and wait the designated time period between doses. I do NOT agree with making your child suffer through it, coughing all night and miserable.

I like the suggestion that parents have to sign for the medicine. Don't punish all of us for something a few idiots do. Report
Will someone quick send a government agent over to my house and help me live my life and take care of my kids? I obviously can't do it by myself. Report
My daughters Dr is a firm beleiver in letting a cold run its course before running to the pharmacy. I've gotten into the habit of waiting 10 days before calling him...unless I see something really troubling. I give her some OTC pain releiver, as she usually has a headache with it. But I let her nose run, and she blows whatever is in there out! She also coughs whatever is down there up. cough supressants and things to dry you up don't do a thing for getting whatever is in there out of there. We do the vaporizor/humidifier as needed, warm liquids, chicken soup, blankets and rest. Nine times out of ten, she is better in less than a week. Only rarely has she gotten worse, and that has been a sinus imfection, due to allergies. Unfortunately, the people who abuse this system now, will only keep doing it. Report
Yes, it seems to be a good idea. I know that the best thing for a cold is to let it run it's course, so I don't run to my medicine cabinet everytime my two year old gets the sniffles. My concern is the people who will continue to give their children improper doses because they will no longer be on the medications. Most parents just want their children to feel better, and who could blame them? We all hate it when our kids get sick. But we also know that there will be well meaning parents out there who will try to "guess" how much their child should take, and still end up in the ER. I don't think that this will solve the problem. I do however agree with the post about making parents/caregivers talk to the pharmacist. Then you can figure out exactly what you need, without going overboard. Report
I don't use anything but tylenol for my toddler, and only when it is VERY OBVIOUS that he isn't feeling well, so I'm not really bothered personally by the new restrictions. However, as a teacher who has many students with uncaring parents, if the parents can't/won't/don't read the label and dose accordingly, they shouldn't be having children. Report
My kids doctor would rather have us call his office and get advice than for us to try any over the counter. Report
Some home remedies can be as bad as the OTC ones. My doctor is dead set against hot steam, cold vaporisers only. I also read that you have to be careful with homemade herbal tea's. Report
If the reason for the change is because of the parents who do not follow or read the directions then whos to say they will notice the label now says 4 instead of 2? Report
We use liquorices and or tea with honey and anis. Report
Being from a family that first practices home remedies its good to see that they are putting the warnings on the label. Even some of the home remedies that I practiced on my now grown daughter are now considered not to be good for small children. Report
I'm glad to see the warnings will be on the labels. But, I think it's sad that parents do not take the time to read the instructions on the medicine bottles. It was pointed out that most of the issues came from people using the medicine improperly. I know it takes extra time, but I check the expiration date before giving a dose to my kids. I also read the bottle to make sure the medicine is treating the symptoms that they have. The pharmacists are also a great resource without having to make an appointment at the doctors. Ultimately, it is our responsibility as parents to be diligent when it comes to our children's well being. If we don't know about the medicine, we have to ask. I hope the new labeling will help avoid more avoidable tragedies. Report
I think this is a step in the right direction. We have some people who do not follow correct dosing for the little ones. I mean even now they still don't. I did use cold medication for my little ones when they were sick. I used it as described and prescribed. What I have found is that alot of parents will purchase the medication not for it's intended use. The some medications will put you to sleep and alot of parents would use the medication to put their kids to sleep not realizing that they could kill them in the process. I am glad the the change has taken place. Where I live you have to have ID to purchase cold medication for children. Report
I have never given any of my kids any cold medicines. I let nature runs its course. Maybe that's why my kids have colds maybe once a year. Report
One of the reasons the FDA decided to do this because there are many parents out there who don't want to deal with their kids; so they drug them with these products to get them to sleep. For those of us who only give the medication when our children really need it, just keep talking with your doctor. A call to your doc will help ease your mind because they will make sure what dose is right for your child's age and weight.
Just remember a cold is just that a cold, so don't be rushing your child to get antibiotics. They won't help the cold, the only thing you will do is make antibiotics less useful in your child.
Washing hands a lot is the best way for your child & you not to catch a cold. Take wipes with you shopping to clean off the cart handles, and also a small bottle of sanitizer. For those who don't have a lot of room for wipes in their purses, just put a few in a baggy.
Good luck this cold and flu season!!
HUGS!!! Report
As a nurse, I can tell you that some people who have children do not understand the labels or choose to ignore them. That being said, I don't think we should all be punished because of this. Perhaps they could make parents sign for the OTC cough/cold meds like I have to do for Sudaphed now. Then the pharmacist could reiterate the importance of not giving too much and whether acetaminophen or ibuprofen are already in the medicine. Pediatricians should also emphasize this information. I know when I worked in pediatrics I always discussed the use of any meds with the parents or caretakers and advised them if they could not use other meds with them. Even my adults patients were told not to take acetaminophen with pain medications or Nyquil because it is already included. Perhaps there just needs to be more education. I am always surprised that people don't know that acetaminophen is Tylenol, ibuprofen is Motrin and Advil. But, then again, why should they know they are not medical personnel. They do not realize that just one too many Tylenol could put you into liver failure and too much ibuprofen can shut down your kidneys. Many people do not realize that you cannot use the spoons you for eating to measure meds as they hold more than a teaspoon or a tablespoon and they must use either a measuring spoon or a graduated medicine spoon. What we really need is a nationwide campaign to help everyone understand what the medications do, what they cannot take with them and what a proper dose is. Report
I notice that most of the people below me are older, not OLD, just older than me, so please don't get offended. But maybe you guys were taught how to make home remedies w/ teas and such that your kids will actually take. I wasn't, my kids don't like tea of any sort, and I have always used OTC meds if they were sick. I have never once had an adverse reaction in either of my kids, except some brands that are cheap and don't work, like Triaminic. But I took Robitussin as a kid, that stuff is nasty, but it works. I can read a label. I can follow directions. And I'm insulted that the government thinks that I can't and therefore must make my child suffer because of the shockingly tiny number of children every year who are harmed, mostly by drinking it themselves. I will continue to use OTC meds if my kids are coughing bad enough that no one gets a good night's sleep, or sneezing green snot. Whatever I have to do to make them feel better. And now they won't have the proper dosage listed for my 3-year old, and she's just going to have to be miserable? Thanks very much oh wise and all knowing FDA. How about working on something that is actually a problem, like ensuring more kids get their shots, are not abused, and oh maybe smoking or something useful? All this is doing is driving up more visits to the doc, so they can give the child the exact same thing that was bought on a store shelf a year ago with a different name. Sorry for ranting so much, but it really bugs me. Report
I remember hearing about that 1.5 years ago. My husband and I were glad because our son had just turned 5 when it came out. We had given our child some meds when he was younger and we wouldn't know what to do without them. Report
I commend the FDA on these labeling guidelines. Too many children have had reactions and even some fatalities. Sometimes common sense just isn'y enough especially for new young parents. Report
I really never used that many OTC cold remedies for my son. Mostly because if he was sick enough to complain, he probably was sick enough to see the doctor. (He was and still is the most non-complaining kid I have ever met!)

That being said, I am again astonished at what the government feels it must do to protect us from what it perceives as our own vast stupidity. I must say I rather resent that stereotype. I don't have a degree in medicine, but I am smart enough to read a label. And truth be told, when my son was little his pediatrician advised never to use multisymptom medicine anyway. Use one medicine to treat each symptom. And some good old common sense. (plenty of clear liquids, sleep, and tylenol or motrin for fever.) Report
OTC cold medicines never work for my son, they would only make him feel worse, so we use home remedies...teas, honey, & steam. I also like the homeopathic medicine called Chestal. If nothing works then it's off to the doctor, but that doesn't happen very often. Report
Thanks for the good info. Report
Awesome information. I'm an Army medic and found this very interesting. I'm going to be sure to pass this information on to my fellow soldiers who have younger children. Report
Thank you for the info. It makes me feel good that when my kids were younger and I didn't give them cold medicines, which at that time went against the norm. Report
When the kids were little we tryed home remedies first. Like Honey and Tea we had cough med from the Dr that worked great but now you can't get because it had coden in it. We used vic's on the chest and back and made them wear a old t-shirt to bed to sweat it out. If that didn't work in 3 days then off to the Dr we would go. Didn't use to many over the counter stuff back then. Now they have to many of them on the counter so how do you know it is safe. Home remedies are the best. Now you can get on line and see what they want you to do also. Even here at Sparks you can look things up in the Health A - Z. Report
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