FDA label 68248a98-3b9f-426d-ac1b-33dfd68aa030

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
7d28682b-fc7d-4c2b-9a83-89df25b5ab2d
SPL ID
68248a98-3b9f-426d-ac1b-33dfd68aa030
Version
2
Effective date
2013-11-08
Source export date
2026-09-28
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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:01:51

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing an NSAID (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 and/or nasal decongestant right before or after heart surgery in a child who is taking a prescription monoamine oxidase inhibitor [MAOI] (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has problems or serious side effects from taking pain relievers, fever reducers, or nasal decongestants stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems not been drinking fluids lost a lot of fluid due to vomiting or diarrhea high blood pressure heart or kidney disease asthma thyroid disease diabetes taken a diuretic Ask a doctor or pharmacist before use if the child is taking any other drug containing an NSAID (prescription or nonprescription) and/or pseudoephedrine or any other nasal decongestant taking a blood thinning (anticoagulant) or steroid drug under a doctor's care for any serious condition taking any other drug When using this product do not exceed recommended dosage 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 the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. stomach pain or upset gets worse or lasts the child does not get any relief within first day (24 hours) of treatment fever, pain, or nasal congestion gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear the child gets nervous, dizzy, or sleepless 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)

Reported adverse events (FAERS/openFDA)#

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