What's New in Cough and Cold Medications for Kids?

OTC GuideJune 2008
Volume 12
Issue 1

Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.

Statistics reveal that an estimated 95 million packages of cough and cold medications are purchased each year for use in children,1 and with the FDA advisory issued earlier this year on the use of these products in the pediatric population, many parents and caregivers will be seeking advice from their pharmacist.

Last fall the FDA assembled a joint meeting of the Pediatric Committee and the Nonprescription Drug Advisory Committee, and this advisory panel issued recommendations on the use of cough and cold preparations in children under 6 years of age. The panel's recommendations were based on results from multiple studies that reported a lack of effectiveness regarding pediatric cold medications and risks of potential adverse effects, especially in children younger than 2 years of age.2,3 Serious adverse effects have been associated with accidental overdose, unintentional misuse, and drug?drug interactions in children given standard doses.1 The panel reviewed the following categories of drugs:

  • Antihistamines
  • Cough expectorants
  • Cough suppressants
  • Decongestants

FDA Advice on the Use of Cough and Cold Products (Aged 2 to 11 years)

Pending completion of the FDA?s ongoing review, parents and caregivers who choose to administer OTC cough and cold medicines to children aged 2 to 11 years should:

  • Follow the dosing directions on the label of any OTC medication
  • Understand that these drugs will not cure or shorten the duration of the common cold
  • Check the Drug Facts label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients
  • Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs
  • The FDA recommends that anyone with questions contact a physician, pharmacist, or other health care professional to discuss how to treat a child with a cough or cold

Adapted from reference 4.

Although many medical experts may agree that the risks from pediatric cough and cold medications may be low, some experts still feel the recommendations are needed.2 On January 17, 2008, the FDA issued a public health advisory recommending that OTC cough and cold products not be used in children under 2 years of age because serious adverse effects can occur.4 The FDA also is working to complete a review on the safety of OTC cough and cold medications in children aged 2 to 11 years and plans to issue a recommendation on the use of these products in this age group once that review is completed.4 The box at right lists the FDA's current advice for children aged 2 to 11 years.

Prior to the FDA panel's recommendations, the Consumer Healthcare Products Association (CHPA) issued a press release in October stating that a number of major manufacturers voluntarily agreed to discontinue the marketing of cough and cold products for children under 2 years of age.5 The CHPA Education Foundation has a Web site (www.otcsafety.org/Parents) for parents seeking information on the use of these medicines in children.

In addition, to assist parents and caregivers in managing colds in children, the American Academy of Pediatrics recommends the following6:

  • Administer acetaminophen or ibuprofen (not aspirin) if fever is present
  • Ensure adequate hydration
  • Use a cool mist humidifier to relieve nasal passages
  • Administer saline nose drops to thin mucus
  • Use a suction bulb in babies to clear mucus

Given these new guidelines for the use of cough and cold products in children, pharmacists should seize every opportunity to ensure that parents and caregivers are counseled effectively about the appropriate use of these medications.


  • Sharfstein, JM, North, M, and Serwint, JR. Over the counter but no longer under the radar-pediatric cough and cold medications. N Engl J Med. 2007;357:2321-2324.
  • Nonprescription Drug Advisory Committee Meeting. FDA Web site. www.fda.gov/~2007-4323b1-02-FDA.pdf.
  • Kid's Cold Medicines: New Guidelines. WebMD Web site. www.webmd.com/a-to-z-guides/kids-cold-medicines-new-guidelines.
  • FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products [press release]. FDA Web site. www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html.
  • Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines [press release]. Consumer Healthcare Products Web site. www.chpa-info.org/~2007/10_11_07_CCMedicines.htm.
  • Childhood Infections. American Pediatric Association Web site. www.aap.org/publiced/BR_Infections.htm.

In 2007, 36,230 acetaminophen overdoses occurred in the United States; of those, 41 individuals died from ingesting too much acetaminophen. Oklahoma, in particular, has seen acetaminophen overdoses?alone or in combination with other drugs?increase to 2078 cases in 2007, compared with 1607 cases in 2003. Lee McGoodwin, managing director of the Oklahoma Poison Center, said that 585 cases have been reported so far this year. Shannon Holcombe, education coordinator for the poison control center, said, "Read the active ingredients. Be careful of multiple medicines with the same ingredients, especially acetaminophen.Follow the directions."

Americans with cholesterol problems would be more likely to consider taking an OTC statin according to a survey of 710 Americans released by the National Consumers League. Overall, the majority of those surveyed (82%) reported that an OTC statin would be preferable to an Rx product. The respondents said that the OTC is more appealing mainly because of convenience factors. They viewed OTC statins as safer, more natural, more suitable for an individual who takes charge of his or her health, and less likely to cause side effects than Rx statins.

The American Dietetic Association recently joined 3 other groups in filing a joint citizen?s petition to the FDA regarding weight-loss claims made by the marketers of dietary supplement?containing aids. The groups want the agency to make changes in the regulation of weight-loss supplements so the manufacturers would be mandated, on the basis of valid scientific evidence, to have prior FDA approval of weight-loss claims. Normally, regulating weight-loss claims made in advertising has fallen under the Federal Trade Commission (FTC). The citizen?s petition argues that if the FDA ruled in favor that weight-loss claims are a disease state claim, the FTC would no longer have regulating authority.

Half of the individuals with back pain take Advil (ibuprofen) and Aleve (naproxen) for relief, according to a poll of 899 individuals conducted by Spine-health.com. The respondents were asked which OTC pain reliever they prefer for back pain or neck pain. The poll showed that ibuprofen in general (Advil, Motrin, and Nuprin combined) accounted for 39% of the responses; 26% of the respondents said Advil is the first choice for pain relief, while 24% chose Aleve; and Tylenol (acetaminophen) was chosen by 11%.

A National Council on Patient Information and Education (NCPIE) survey showed that most adults self-medicate with OTC medicines for themselves and their children without consulting a pharmacist or other health care provider, which may put them at risk. The survey found that 76% of respondents recognizedthat self-medicating with OTC medications can pose possible risks, and more than 4 in 5 adults typically self-medicate for various health conditions that they have experienced in the past year that may be treated or relieved by OTC medications, the most common of which are colds (56%), coughs (37%), and seasonalallergies (29%).

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