omeprazole

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)

Brand name
omeprazole
Generic name
OMEPRAZOLE
Manufacturer
INNOVUS PHARMACEUTICALS, INC.
Product type
HUMAN OTC DRUG
SPL set ID
ce5c9fdc-0c50-4315-8f11-e00c9810abd0
SPL ID
ce5c9fdc-0c50-4315-8f11-e00c9810abd0
Version
1
Effective date
2020-08-06
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 06:35:09
Harmonized routes table
Harmonized routes
ORAL

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 ■ 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 before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. 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 ■ 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 (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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