Pediatric Over-the-Counter Acetaminophen Labeling and Packaging Updates

Pharmacists may see a change in the packaging and labeling of select over-the-counter (OTC) acetaminophen products. Current OTC liquid acetaminophen products on the market do not have standardized concentrations, labeling, or dosing devices.

In August 2015, the US Food and Drug Administration (FDA) released a guidance document for the packaging and labeling of OTC pediatric liquid products containing acetaminophen.¹ The guidance document applies exclusively to liquid, oral, single-ingredient, or combination acetaminophen products marketed for children aged <12 years.¹ It is important to note that this guidance does not apply to products labeled for children and adults, or adults only. The purpose of this guidance document is to reduce the risk of acetaminophen-related liver damage because of unintended overdosing or accidental ingestion.¹ The document outlines specific recommendations for product concentrations, labeling, and associated drug delivery devices.

Uniform Concentrations

The guidance suggests a uniform concentration of 160 mg per 5 mL of acetaminophen, for all single-ingredient acetaminophen oral liquids.¹

Single-ingredient liquid acetaminophen products are available as concentrated drops of 80 mg per 0.8 or 1 mL, in addition to 160 mg per 5 mL oral liquid. In 2011, it was announced that manufacturers would voluntarily discontinue production of concentrated drops.² Many—but not all—manufacturers have followed suit. Pharmacists should expect the concentrated drops to gradually disappear from retail shelves. Standardizing single-ingredient concentrations will reduce dosing confusion, as well as the risk for accidental over- or underdosing.

Standardized Labels

The guidance document suggests standardizing labeling information for all products to improve readability of concentration and dosing instructions.¹ Unfortunately, the FDA has not recognized weight-based dosing as the preferred dosing method. Age-range dosing may still be seen on labeling of single and combination products. The American Academy of Pediatrics states that weight-based dosing is the preferred method for determining an optimal dose.³ Pharmacokinetic, safety, and efficacy data support a 10- to 15-mg/kg dose for children aged 6 to 24 months; however, product labels may not have instructions for children aged <24 months.^1,2,4 Many pediatricians instruct parents and caretakers to use OTC acetaminophen-containing products for their children aged 6 to 24 months, without explaining the appropriate dose.

The lack of specific labeling instructions for children aged 6 to 24 months will remain a source of confusion for parents and caretakers.² However, the Know Your Dose campaign is sponsored by the Acetaminophen Awareness Coalition to educate consumers on how to safely use acetaminophen products.⁵ Free dosing guides for infants and children are available on their website, in addition to other educational materials. When counseling parents and caretakers on appropriate dosing of acetaminophen products for children aged 6 to 24 months, a weight-based dosing chart, application, or calculator may serve as a helpful patient guide.

Delivery Devices

The guidance recommends the inclusion of calibrated dosage delivery devices in product packagings with only millimeter markings to reduce confusion.¹ Dosing devices that include multiple measurement scales, such as teaspoons and drams, can increase the risk for dosing errors.⁶ There are varieties of delivery devices sold separately, in addition to the devices included in the product packaging. For example, PediDose is a children’s acetaminophen doser that includes weight markings to improve dosing accuracy and reduce the risk of calculation errors.⁷

Pharmacists should familiarize themselves with available dosing devices, and offer to counsel parents and caregivers on product dosing. When counseling parents and caregivers, pharmacists should always demonstrate the correct dosage marking for the device, based on the child’s age or weight.

Conclusion

The FDA industry guidance is a step in the right direction to reducing the risks for pediatric overdose and acetaminophen-related medication errors. Drug manufacturers, labelers, and packagers of OTC, pediatric, oral liquid products containing acetaminophen should implement the packaging and labeling suggestions, although they are not required. Pharmacists and other healthcare providers should be aware of the risks associated with combination products marketed for children, and continue to counsel parents on appropriate dosing for their children.

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References

1. US Food and Drug Administration; US Department of Health & Human Services. Over-the-counter pediatric oral liquid drug products containing acetaminophen; guidance for industry; availability. Fed Regist. 2015;80:46588-46589.
2. Consumer Healthcare Products Association. OTC industry announces voluntary transition to one concentration of single-ingredient pediatric liquid acetaminophen medicines [news release]. www.chpa.org/05_04_11_pedacet.aspx. Published May 4, 2011. Accessed November 9, 2015.
3. Perrin JM (American Academy of Pediatrics, Grove Village, IL). Letter to: Tau A (Food and Drug Administration, Rockville, MD). 2014 Dec 8.
4. Hoover L. AAP reports on the use of antipyretics for fever in children. Am Fam Physician. 2012;85:518-519.
5. Acetaminophen Awareness Coalition. Know Your Dose website. www.knowyourdose.org/. Accessed November 9, 2015.
6. National Alert Network. Move toward full use of metric dosing: eliminate dosage cups that measure liquids in fluid drams. Use cups that measure mL. www.nccmerp.org/sites/default/files/nan-alert-june-2015.pdf. Published June 30, 2015. Accessed November 9, 2015.
7. PediDose. Children’s Acetaminophen Dosers. Available from: http://pedidose.com/products/childrens-acetaminophen-dosers/