Please explain the FDA regulations about cold products for children.
In January 2008, the Food
and Drug Administration (FDA) issued a nationwide Public Health Advisory recommending that
over-the-counter (OTC) cold and cough products not be used to treat children under 2 years of
age because of the risk of serious and life-threatening side effects.
Then, in October 2008, the FDA said it supports the voluntary action of the Consumer Healthcare Products Association (CHPA) to change the labeling on many OTC cold and cough products for children. (CHPA represents most manufacturers of these products.)
The label change will recommend that some products not be given to children under the age of 4 years because of the risk of serious and potentially life-threatening side effects; labeling on some products will recommend against their use for children under age 2 years. Previously, most of these products were not advised for children under age 2 years.
The voluntary label change is intended to help prevent and reduce the misuse of these products in children, as well as to better inform consumers about their safe and effective use. These manufacturers also are introducing new child-resistant packaging and new measuring devices for use with their products.
The FDA also offers these medication safety tips for parent and caregivers:
- Do not give children medications that are labeled only for adult use.
- Always consult your doctor or pharmacist if you have any questions about using cough or
cold medicines in children.
- Choose OTC cough and cold medicines with child-resistant safety caps, when available. Keep
them tightly closed and out of the reach of children when not in use.
- Read the "Active Ingredients" section of the "Drug Facts" label of the medicines you
choose. It tells which symptoms the active ingredients are 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 and fever reducer.
- If you are giving more than one medicine to a child, make sure the medicines do not have
the same type of active ingredients. If you use two medicines that have the same or similar
active ingredients, your child could be harmed by getting too much of that ingredient.
- Always follow the directions for how to use the medicine in the "Drug Facts" part of the
label: how much to give and how often you can give it. If you have any questions about how to
use the medicine, ask your pharmacist or other healthcare professional. Overuse or misuse of
these products can lead to serious and potentially life-threatening side effects, such as rapid
heartbeat, drowsiness, breathing problems, and seizures.
- Only use measuring devices (cup, spoon, dropper,
for example) that come with the medicine or those specially made for measuring drugs. Household
spoons come in different sizes and are not meant for measuring medicines.
- Remember that OTC cough and cold medicines do not cure the cold or cough - they only treat
symptoms, such as runny nose, congestion, fever, and aches. And they do not shorten the length
of time your child is sick.
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