FDA label 1504d1d2-4583-4fc2-bd86-ff448cfdf658

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
54394aec-a36b-427f-9be4-76e3768595c6
SPL ID
1504d1d2-4583-4fc2-bd86-ff448cfdf658
Version
2
Effective date
2011-04-29
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:33:28

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warning Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking clopidogrel bisulfate (anti-blood clotting medicine) warfarin (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) atazanavir (medicine for HIV infection) Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-2221222)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.