FDA label 1658e69c-3b21-4829-b2fc-1234e7ff37f4

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
1fa232d5-1997-49b2-bf4f-361652e50a6e
SPL ID
1658e69c-3b21-4829-b2fc-1234e7ff37f4
Version
2
Effective date
2018-01-01
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 02:23:23

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: _ blisters _ rash _ hives _ asthma (wheezing) _ shock _ skin reddening _ facial swelling 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: _ take a blood thinning (anticoagulant) or Drug Facts (continued) steroid drug _ are age 60 or older _ have had stomach ulcers or bleeding problems _ 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 Do not use _ if you have ever had an allergic reaction to any other pain reliever/fever reducer _ right before or after heart surgery Ask a doctor before use if _ stomach bleeding warning applies to you _ you have a history of stomach problems, such as heartburn _ you are taking a diuretic Drug Facts (continued) _ you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma _ you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are _ taking any other drug _ under a doctor's care for any serious condition _ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 experience any of the following signs of Drug Facts (continued) stomach bleeding: _ feel faint _ have stomach pain that does not get better _ have bloody or black stools _ vomit blood _ pain gets worse or lasts more than 10 days _ fever gets worse or lasts more than 3 days _ redness or swelling is present in the painful area _ 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. 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) Drug Facts (continued)

Reported adverse events (FAERS/openFDA)#

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