ibuprofen

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
ibuprofen
Generic name
IBUPROFEN
Manufacturer
DOLGENCORP INC
Product type
HUMAN OTC DRUG
SPL set ID
8f1358aa-495a-23da-e053-2995a90aa430
SPL ID
f0b3ed7d-1622-3990-e053-2995a90ae520
Version
3
Effective date
2023-01-02
Source export date
2026-10-27
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/2026-10-27/6f51a1483736359ffd78ed7be27289bc51f2a8463b934465bee40efbdef4dfd7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 21:06:03
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 · 2 matching rows.

warnings

WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) blisters facial swelling hives rash shock skin reddening If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is 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 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 Heart attack and stroke warning: NSAID's except aspirin increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.

warnings table

<table border="0" width="100%"><tbody><tr><td><content styleCode="bold">WARNINGS</content><paragraph><content styleCode="bold">Allergy alert:</content> Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: </paragraph><paragraph>asthma (wheezing) blisters facial swelling hives rash shock skin reddening </paragraph><paragraph>If an allergic reaction occurs, stop use and seek medical help right away. <content styleCode="bold">Stomach bleeding warning:</content> This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: </paragraph><paragraph>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 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 </paragraph><paragraph><content styleCode="bold">Heart attack and stroke warning: </content>NSAID&apos;s except aspirin increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed. </paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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