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Child Warning Labels Added to Over-The-Counter Cough and Cold Medicine

10/22/2009 | Return to All Current News

New product labels on over-the-counter cough and cold preparations state they should not be used by children younger than 4 years of age — a warning the Oklahoma Poison Control Center advises parents to heed. Until recently, medications used to treat the symptoms of cough and cold had never been studied in children. Their effectiveness and safety are still unknown. The Food and Drug Administration already has recommended OTC remedies not be used for children under 2 years of age.
 
As studies continue regarding the effectiveness of OTC medicines for children under 12, the FDA has expressed support of the Consumer Healthcare Products Association’s move to voluntarily change labels to discourage use for children under 4 years old — a decision that was made in 2008. This change will not make the medicine unavailable, but may result in a period of time during which the instructions may vary from brand to brand.
 
A recent study by the American Academy of Pediatrics found that more than 7,000 children per year take a trip to the emergency room due to side effects suffered from OTC cough and cold medicines. Side effects include breathing problems, dizziness, increased heart rate and high blood pressure. “In addition to the possible side effects of the medications, there is a danger of unintentional overdose,” said Lee McGoodwin, managing director of the Oklahoma Poison Control Center. “Children may find the medicine on the counter and take a drink or a family member may give them a dose of a multi-symptom cold medication along with children’s pain reliever. Both of these products may contain acetaminophen, and now the child has received a double dose of it. Acetaminophen can be very toxic and can cause liver failure.”
 
Although many products containing acetaminophen are approved as fever reducers for children, parents should not give the medicine more often or in greater amounts than is stated in the “Drug Facts” box located on the package, nor pair it with another product that also contains acetaminophen. Such actions may lead to life-threatening side effects.
 
The Oklahoma Poison Control Center recommends the following alternatives that may help soothe your child’s symptoms:
  • Saline nose spray can help ease stuffy noses.
  • Have him or her drink plenty of fluids. Any warm liquid — apple juice or even water — can help relieve congestion and soothe throats. The only exception is citrus drinks, which may irritate throats.
  • Getting plenty of rest, including naps and lounging, is important for recovery.
  • Flavored ice pops can provide a source of liquid that soothes the throat and hydrates the body.
  • Hot or cold packs can be applied around congested sinuses. Both can make your child feel more comfortable, but avoid a hot pack if the child is running a fever — it will raise the temperature. • Place a small dab of petroleum jelly on the upper lip to lessen chafing from a runny nose.
  • Drain the heavy syrup from canned peaches and have the child drink it to help soothe sore throats.
  • Honey often is recommended to help soothe sore throats, but it should never be given to children less than 1 year of age because of the risk of infant botulism, a rare type of food poisoning.
  • Chicken soup is warm and easy on the stomach. In addition, steam from the soup ventilating into the nasal passages can serve as a natural decongestant. (Just make sure to limit salt since that can cause dehydration.)
 
If your child experiences any of the conditions listed below, consult your doctor:
  • fever accompanied by vomiting or rash • difficulty breathing, rapid breathing or labored breathing
  • fever of more than 100.4 degrees (Centers for Disease Control)
  • signs of lethargy or low energy, even after treatment is given Additionally, if your child is sick for more than a week even without a fever, he or she could have a sinus or ear infection that needs treatment.
 
Pharmacists and registered nurses at the poison center are available 24 hours a day, seven days a week at 1 (800) 222-1222. Do not e-mail the poison center or a member of the poison center staff, as poisoning emergencies are not handled through e-mail. The Oklahoma Poison Control Center is a program of the University of Oklahoma College of Pharmacy at the OU Health Sciences Center. For more information, please visit www.oklahomapoison.org.