FDA label ec097ccf-571e-460b-8772-0baa0ade5dfd

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
049347a1-b4a3-4752-988d-3e75e3bbffda
SPL ID
ec097ccf-571e-460b-8772-0baa0ade5dfd
Version
3
Effective date
2021-01-20
Source export date
2026-08-01
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/2026-08-01/63703fa640102c69d41ceeb8d73f46d0a0be448587814b2aeca60b43bed7e054/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:37:02

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 • blisters 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 your child: • has had stomach ulcers or bleeding problems • takes a blood thinning (anticoagulant) or steroid drug • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • takes more or for a longer time than directed Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use • if the child has 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 your child • child has a history of stomach problems, such as heartburn • child has problems or serious side effects from taking pain relievers or fever reducers • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • child has high blood pressure, heart disease, liver cirrhosis, or kidney disease • child has asthma • child is taking a diuretic Ask a doctor or pharmacist before use if the child is • under a doctor’s care for any serious condition • taking any other drug When using this product • mouth or throat burning may occur; give with food or water • 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 • child experiences any of the following signs of stomach bleeding: • feels faint • vomits blood • has bloody or black stools • has stomach pain that does not get better • the child does not get any relief within the first day (24 hours) of treatment • fever or pain gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear 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)