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.
Contact your child's pediatrician or another health care professional regarding the use of any medication. Try home remedies such as honey and lemon for sore throats and dry coughs and saline solution and a bulb syringe for congestion--after discussing them with your health-care provider. (Note: Do not give honey to children younger than 1 year.) Running a humidifier during cold, dry months can also help children and ease congestion.
In addition, the FDA offers these 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 especially 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.
Tanya Jolliffe, a BabyFit nutritionist, reviewed this article.
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