Understanding over-the-counter medications and warning labels

Consumers who suffer adverse effects from a dangerous or defective medications may have legal recourse, especially when the product labeling is insufficient. In Tennessee and around the country, there are laws that require manufacturers to alert people about any potential side effects the drug is known to have.

According to the Food and Drug Administration, the following information must be contained on the warnings for an over-the-counter drug label

  •        The conditions that would require a consumer to consult with a physician prior to taking the medication
  •        Circumstances that should prevent a consumer from taking the medication
  •        When to call a physician
  •        When to cease taking the medication
  •        A warning to keep the medication away from children

Additionally, the label should alert pregnant or breastfeeding mothers to speak with a health care professional before taking the medication. The FDA notes that these warnings are especially important when taking over-the-counter medications because they are often taken without first consulting with a physician.

An insufficient warning label can lead to serious injuries. In many cases, the victim will be able to hold a negligent manufacturer or pharmaceutical company responsible. Under Tennessee law, product liability lawsuits must be filed within one year of the incident. The Tennessee Consumer Protection Act gives patients protection from deceptive business practices, including improper labeling.

To prove the defendant is liable for damages, the plaintiff will have to demonstrate negligence and show the act directly caused the injury. While a lawsuit cannot undo the damage that has been done, it can compensate a victim for the expensive medical treatment and emotional burden, among other losses.

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