FDA label 44ec1a5b-a901-0b40-e054-00144ff8d46c

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
c1869597-6f79-420b-9d44-ef39b8665b9b
SPL ID
44ec1a5b-a901-0b40-e054-00144ff8d46c
Version
2
Effective date
2016-12-30
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:01:37

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

WARNINGS Allergy alert: Do not use if you are allergic to omeprazole 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. •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 of 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 taking •warfarin, clopidogrel or cilostazol (blood-thinning medicines)•prescription antifungal or anti-yeast medicines •diazepam (anxiety medicine)•digoxin (heart medicine)•tacrolimus (immune system medicine) •prescription antiretrovirals (medicines for HIV infection) •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•you get diarrhea ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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