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FDA Recommendation: No Cold Medicine for Infants or Toddlers

FDA Recommendation: No Cold Medicine for Infants or Toddlers

In October 2007, the FDA recommended that no over-the-counter pediatric cough and cold medicines be administered to children under age 2 due to the risk of serious and life-threatening side effects including rapid heart rates, convulsions and loss of consciousness. The American Academy of Pediatrics has extended this to recommended against using them in children under age 3 unless advised by a doctor.

In response to the FDA studies, many pharmaceutical manufacturers voluntarily withdrew cough and cold medicines labeled for “infants.” However, many liquid formulations for older children remain on the market and parents may be tempted to administer these to their sick infants.

Most reports of serious problems came from parents accidentally overdosing children by combining multiple medicines or inaccurately measuring dosages in the provided droppers or cups. The FDA is committed to completing a comprehensive review of the safety of these medicines in children 2 years of age and older and will communicate their recommendations to the public as quickly as possible. 

Since most colds are indeed self-limiting and there is no evidence that children’s cold medicines are effective in relieving cold symptoms in infants and toddlers, inviting the risks associated with these medicines is unwarranted.

The FDA is continuing to investigate this issue, with concerns that pediatric cold medicines for older children might need to be banned as well.

Here are the FDA recommendations:

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

A Few Care2 Natural Tips
Maintain good indoor air quality to minimize contributions to respiratory infection. Take the Seventh Generation Indoor Air Test
to see how clean the air in your home is.

Use an aromatherapy diffuser to purify the air in your home, possibly helping to prevent the development of colds.
Click here for tips and treatments.

Read more: Family, Babies, Children, , , , , ,

By Terri-Hall Jackson, contributing writer to Care2's Green Living

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Annie B. Bond

Annie is a renowned expert in non-toxic and green living. She was named one of the top 20 environmental leaders by Body and Soul Magazine and "the foremost expert on green living." - Body & Soul Magazine, 2009. Learn Annie's latest eco-friendly news on anniebbond.com, a website dedicated to healthy and green living.

8 comments

+ add your own
9:13AM PST on Dec 10, 2010

good post

3:31AM PDT on Aug 21, 2010

My health nurse has told me that honey is no longer recommended & is in fact strongly cautioned against for infants less than 2 years due to the incidence of botulism, potentially in (largely untreated) honey. Babies are apparently much more susceptible to this than adults. There have been infant deaths in Canada in recent times as a result so be careful with honey remedies- although once they're older I'm a big fan! Sterilised honey is ok after 1 year and any honey after 2 years is fine.

5:37PM PST on Mar 5, 2008

Honey should not be given to children less than 1 year of age due to possible allergic reactions.

In regards to children and illness:
"Catching colds" are how the immumune system forms. Up until around the age of 5, your child's immune system is creating "memories" of all the illnesses and bacteria which have invaded the blood stream. Then if your child comes into contact with these germs later, their immune system "remebers" them and already has the tools (anti-bodies) to attack them. It is the bodies built in vaccination system. That is why it is important to let a disease run its course. **but make sure to consult a physician to make sure it is not a life-threating disease*** There are other warning signs such as high fever, loss of consciousness, etc that require medical attention immediately.

Try homeopathic medicines for children! They are effective (as long as you pick the right one) and safe. Also increase liquids, avoid sugar, and limit dairy products when your child is ill.

The main problem with over-the-counter medicines for children is that people WERE NOT following the directions. I feel that alot of this is due to the fact that 70% of the U.S population is somewhere between a 5-8th grade reading level (I don't remember the exact reading level but it was somewhere between there).

If you want a natural alternative to prescription drugs consult your local herbalist... there are quite a few of us!

7:52AM PST on Feb 26, 2008

My kids Doctor told me about The Heart Risks some time ago My son is Now two. (also have a 5 yr old) but she told me before It was bad for them. HONEY is bad for BABIES... **Everyone remember to ask a doctor or whomever you see responsable enough for before useing something on children, Check dont just do.*** Just like when your pregnant and cant have tuna or a lot of it, Or Cant have Unpasturised things such as cheese which can cause you to miscarry.There are a lot of things your not saposto give to your kids right away, Like eggs not till they are 1, or nuts not till they are 2.. I cant remember honey though.. Check with your doc (sorry its long)

8:29PM PST on Feb 24, 2008

Honey given to babies can cause (not will cause) an allergic reaction and is not recommended.

4:40PM PST on Feb 15, 2008

This winter I have been using a simple remedy at the first sign of a cold. A small spoon of organic honey dipped in cinnamon, given 3 times daily for 3 days tops. Works like magic!

11:29PM PST on Feb 12, 2008

of course it would also be good to tell people that over the counter and even some prescriptions are dangerous and often don't do what they say they can; they are manufactured by companies that care about money not people's health. my kids have never been to doctors for colds and the only thing i ever used was elderberry (sambucol in the past but now that the company sold and the new one changed the formula to artificial stuff it doesn't work as well, i highly recommend other elderberry, zinc, vit c ('course) and REST! rest! and more rest--fever is part of our amazing body's healing mechanism, and sickness is often an important rest or growth time. anything that tries to stop or hinder that is just counter productive and makes it worse! in an article i wrote in college 'healthcare warfare; alternative medicine vs. industry giants' i found (in doing the research) that the medicine industry is hugely corrupt and unhealthy and evidence that many drug are not effective or they serve to actually keep us dependent (how can the industry earn their precious money if we all get healthy or take our health into our own hands or (heaven forbid) go out and pick some herbs, gather berries or garlic and heal ourselves! caugh medicines, OYE, one source in the article i did said a shot of wisky will do the same thing!

5:27PM PST on Jan 29, 2008

In addition to the suggestions above, I've found the old tried & true methods to be very effective:
- Saline nasal spray
- Humidifier at night
- Menthol-rub before bed - turn it into a tickle game for some real fun
- Elevate the crib mattress at night with diapers or a towel under one side of the crib, or a rolled up towel under the pillow if your child is old enough

You may have to adjust your child at night if you've elevated the bed - they like to move around! :)

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Disclaimer: The views expressed above are solely those of the author and may not reflect those of
Care2, Inc., its employees or advertisers.

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