FDA label 5b04f51e-2b48-492b-84b1-22e988d46720

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
bb7e658c-dab5-43b3-b5c2-578948164e63
SPL ID
5b04f51e-2b48-492b-84b1-22e988d46720
Version
3
Effective date
2012-10-10
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:02

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 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. 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 warfarin or clopidogrel (blood-thinning medicine) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) preswcription antretroivirals (medicines for HIV infection) Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088 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.

Reported adverse events (FAERS/openFDA)#

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