Drug Information |
Questions and Answers on Prilosec OTC (omeprazole)
The FDA is announcing the approval of Prilosec OTC (omeprazole) as an over-the-counter (OTC) drug product. Until today, Prilosec was available only with a doctor’s prescription. FDA originally approved prescription Prilosec in 1989. Prilosec OTC is used to treat frequent heartburn. Heartburn occurs when the stomach contents back up and out of the stomach into the esophagus (the tube that connects the throat to the stomach). Frequent heartburn is when you have heartburn 2 or more days a week. Prilosec OTC is not the right medicine for you if you have occasional heartburn, one episode of heartburn a week or less, or if you want immediate relief of heartburn. It is very important that you carefully read and understand the
Prilosec OTC label directions, warnings, and side effects. Most
importantly, the label will tell you when you should seek medical
attention instead of taking Prilosec OTC. Prilosec OTC stops the stomach from making acid. This causes less
heartburn. Both prescription Prilosec and Prilosec OTC contain the same active
ingredient, omeprazole, which effectively stops acid production.
Prescription Prilosec treats diseases that require diagnosis and
supervision by a doctor. Prilosec OTC treats only symptoms of frequent
heartburn. Used as directed, Prilosec OTC will not treat the conditions
that prescription Prilosec treats. Prilosec OTC is a delayed-release 20mg tablet, taken once a day (every 24 hours) for 14 days before eating. You should not take it for more than 14 days or repeat a 14-day course more often than every 4 months unless directed by a doctor. Do not crush, break, or chew the tablet. This decreases how well Prilosec OTC works in the body. No. Prilosec OTC is not intended for immediate relief of occasional heartburn. Prilosec OTC may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours. Although the two products contain omeprazole, prescription Prilosec is for treating conditions such as inflammation of the esophagus (esophagitis), ulcers, and other medical conditions for which a doctor’s supervision is needed. For this reason, stop taking Prilosec OTC and tell your doctor if you: Prilosec OTC is not appropriate for adults who: Do not take Prilosec OTC if you have: When you are taking Prilosec OTC, it is especially important that your health care provider know if you are taking any of the following: There are other OTC drug products used to provide immediate relief
for heartburn. These include
antacids and acid reducer drug products such as Pepcid, Zantac, Tagamet,
and Axid. Prilosec OTC should not be confused with these products
because it works differently and is not intended for immediate relief. Although side effects from Prilosec OTC are not common, they can occur. Tell your doctor if any of these symptoms are severe or do not go away: You can report a side effect the following ways: The company marketing Prilosec OTC makes the decision on
availability. For further information, please contact the
manufacturer, Procter and Gamble, directly. If you have further questions regarding Prilosec OTC or any medications, please contact the Center for Drug's Division of Drug Information at: 888-INFOFDA (888-463-6332), or email us at: druginfo@cder.fda.gov. Back to Top Back to Prilosec OTC Information Page FDA/Center for Drug Evaluation and Research |