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FDA updates label requirements for OTC non-aspirin NSAIDs

updated NSAID warnings

The US Food and Drug Administration (FDA) recently required an update to the Drug Facts labeling of all adult, children’s, and infants’ non-aspirin over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs), for example, Motrin®, Advil®, and Aleve® products.

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These changes strengthen and expand existing warnings relating to the risk of heart attack and stroke associated with NSAIDs.

Download an NSAID label comparison illustrating these changes to aid in discussions with your patients.

TEACH

REMIND

REASSURE

Counsel patients on OTC pain relievers

TEACH

REMIND

  • Help your patients understand that some OTC pain relievers may be more appropriate for them based on their age, health conditions, and other medicines they take.
    Download a Health Conditions Chart that can help them make the most appropriate choice

  • Encourage your patients to always read and follow the Drug Facts label before taking any medication, and to contact you if they have any questions

REASSURE

  • Convey to your patients that, NSAIDs can provide safe, effective pain relief when taken as directed

Survey finds many Americans do not consider key safety factors when choosing OTC pain relievers

OTC pain reliever considerations

A recent survey1 conducted by the US Pain Foundation, with support from Johnson & Johnson Consumer Inc., found that 97% of Americans feel confident when choosing which type of over-the-counter (OTC) pain medicines to take. However, the survey also revealed that many consumers disregard critical safety factors—such as their age, health conditions, and other medicines they are currently taking—when choosing an OTC pain reliever.

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Reference: 1. In July 2016, the U.S.Pain Foundation, with support from Johnson & Johnson Consumer Inc., conducted a survey on American consumers' perceptions and behaviors when it comes to the appropriate selection and use of OTC pain relievers. The survey was conducted from June 24-July 5, 2016 among nearly 1,300 U.S. adults who have used an OTC pain reliever in the last 90 days. The survey included an oversampling of respondents with high blood pressure (n=125) and respondents who have cardiovascular disease (n=125).