FDA label bc246c0a-092e-9386-4674-d4fb8932f2ec

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
b7289621-9dc7-fd2b-bbb1-f69dea450f7d
SPL ID
bc246c0a-092e-9386-4674-d4fb8932f2ec
Version
4
Effective date
2025-12-01
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:37

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

WARNINGS SECTION 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 • 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 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 • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or Pharmacist beofre using if you are taking: • warfarin, clopidogrel or cilostazol (blood thinning medications) • prescription antifungal or anti-yeast medicines • diazepam (anxiety medicine) • digoxin (heart medicine) • tacrolimus or mycophenolate mofetil (immune system medicines) • prescription antiretrovirals (medicines for HIV infection) • methotrexate (arthritis medicine) 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 treatement every 4 months •you get diarrhea •you develop a rash or joint pain 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 (1800-222-1222)

warnings

Allergy alert Do not use if you are allergic to Omeprazole

Reported adverse events (FAERS/openFDA)#

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