FDA label 496132f0-e76a-4605-e063-6394a90a16aa

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
1cbace4d-fd0a-41d1-aa71-907d43620bf8
SPL ID
496132f0-e76a-4605-e063-6394a90a16aa
Version
3
Effective date
2026-01-27
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:27:46

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 2 of 3 · 11 matching rows.

warnings

Warnings – Alcohol Prep Pads For external use only Flammable, keep away from fire or flame Do not use – Alcohol Prep Pads with electrocautery procedures in the eyes. If contact occurs, flush eyes with water. Stop use if – Alcohol Prep Pads irritation and redness develop. If condition continues, consult your health care practitioner Keep out of reach of children. – Alcohol Prep Pads If swallowed get medical help or contact a Poison Control Center right away.

warnings

Warnings – Hand Sanitizer For external use only Flammable, keep away from fire or flame. Keep out of reach of children. – Hand Sanitizer Do not use – Hand Sanitizer in eyes, if this happens, rinse thoroughly with water. Stop use, ask a doctor if – Hand Sanitizer irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

warnings

Warnings – Ibuprofen Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • skin reddening • asthma (wheezing) • facial swelling • rash • shock • 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 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 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 Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use – Ibuprofen 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 – Ibuprofen you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic Ask a doctor or pharmacist before use if you are – Ibuprofen taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor’s care for any serious condition taking any other drug When using this product – Ibuprofen take with food or milk if stomach upset occurs Stop use and ask a doctor if – Ibuprofen • you experience any of the following signs of stomach bleeding feel faint • vomit blood have bloody or black stools have stomach pain that does not get better • you have symptoms of heart problems or stroke chest pain • trouble breathing weakness in one part or side of body slurred speech • leg swelling • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • redness or swelling is present in the painful area • any new or unexpected symptoms occur If pregnancy or breast-feeding, – Ibuprofen ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless specifically 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. – Ibuprofen In case of overdose, get medical help or contact a Poison Control Center right away.

warnings

Warnings – Acetaminophen Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: – Acetaminophen Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use – Acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have – Acetaminophen liver disease Ask a doctor or pharmacist before use if – Acetaminophen you are taking the blood thinning drug warfarin Stop use and ask a doctor if – Acetaminophen pain gets worse and lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition If pregnant or breast-feeding, – Acetaminophen ask a health professional before use. Keep out of reach of children. – Acetaminophen Overdose warning: – Acetaminophen In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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