FDA label 48ac020b-2b39-4005-90e5-393aaf4accfb

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
9fb7fffb-ae3c-4cba-82d8-168b4db7945b
SPL ID
48ac020b-2b39-4005-90e5-393aaf4accfb
Version
3
Effective date
2018-01-30
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:22:50

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: 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 and blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, if you take a blood thinning (anticoagulant) or steroid drug, if you take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others), if you have 3 or more alcoholic drinks every day while using this product, or if you take more or for a longer time than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer or right before or after heart surgery. Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers, if you have stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain, ulcers, bleeding problems, high blood pressure, heart or kidney disease, asthma, taken a diuretic or reached age 60 or older. Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription), if you are taking a blood thinning (anticoagulant) or steroid drug, if you are under a doctor's care for any serious condition, if you are taking aspirin to prevent heart attack or stroke because ibuprofen may decrease this benefit of aspirin or if you are taking any other drug. When using this product take with food or milk if stomach upset occurs. The risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. Stop use and ask a doctor if pain gets worse or lasts more than 10 days, if fever gets gets worse or lasts more than 3 days, stomach pain or upset gets worse or lasts, if redness or swelling is present in the painful area or if any new symptoms appear. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. TAMPER-EVIDENT: each tablet is individually sealed. Do not use if blister is torn or broken.

Reported adverse events (FAERS/openFDA)#

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