Prescription Drug Labels Are Changing for the Better

Prescription drug label changes for betterLearn more about your medicines.

A new rule that started June 30, 2015 has made it easier for men and women to understand how their medications can affect pregnancy, breastfeeding, and their ability to have children in the future.


Prescription drug labels must now include:

  • More up-to-date drug information about the benefits and dangers to pregnant and breastfeeding women, instead of using the letters A, B, C, D, and X to show the different levels of safety for each prescription drug.
  • More information for doctors and health care providers so that they can give better advice to women about using prescription drugs when pregnant or breastfeeding.
  • Up-to-date drug information for men and women who may have children in the future.


New sections on drug labels:

  • Pregnancy includes labor and delivery and lists any study that collects information about women who took the drug while pregnant
  • Lactation includes information for nursing moms about using the drug while breastfeeding and any possible side effects on the breastfed baby
  • Females and Males of Reproductive Potential includes advice about pregnancy testing and birth control, as well as information about how the drug may affect men and women’s ability to have children in the future

Learn more about your medicines online. 


Keep in mind that these new rules do not apply to over-the-counter drugs.

Talk to your doctor or health care provider for more information.

If you don’t have a doctor, find a health center near you.

cell phone
Call 855 – 543 – 3784 (option 4) to speak with someone from FDA for more information about prescription drugs. Mon – Fri 8:00 AM – 4:30 PM Eastern time.




Pregnancy and Lactation Labeling Rule. Food and Drug Administration web site. Published December 03, 2014. Accessed April 28, 2015.


Updated January 11, 2016

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