boxed warning
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
FDA label 7fb01e10-0e7e-0bba-e053-2991aa0afb2b
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
- SPL set ID
- 6347e7c2-9e5c-49d3-a982-389f1b94e365
- SPL ID
- 7fb01e10-0e7e-0bba-e053-2991aa0afb2b
- Version
- 3
- Effective date
- 2019-01-17
- Source export date
- 2026-08-17
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-17/28baf16af715ee15453297f68cf3645a4d0fd0920220426fbe9d0c3d228bd86d/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
- Import run
- 20260818T065550Z
- Imported at
- 2026-08-18 07:23:19
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 7fb01e10-0e7e-0bba-e053-2991aa0afb2b | id | |
| spl set id | 6347e7c2-9e5c-49d3-a982-389f1b94e365 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing)shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe bleeding. The chances are higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed