FDA label f70af04f-9e1a-61e1-e053-6294a90ab4eb

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
bb5456f0-c202-4717-9668-9c9dce2daefd
SPL ID
f70af04f-9e1a-61e1-e053-6294a90ab4eb
Version
4
Effective date
2023-03-16
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:28:14

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 Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin (NSAID) may cause a severe allergic reaction which may include: • hives • skin reddening • facial swelling • rash • asthma (wheezing) • shock • blisters If an allergic reaction occurs, stop use and seek medical help right away. Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product 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 Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • for pain for more than 10 days unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • if you ever have had an allergic reaction to any other pain relievers/ fever reducers • right before or after heart surgery • if you are taking prescription drugs for gout, diabetes, or arthritis Ask a doctor before use if • stomach bleeding warning applies to you • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have a history of stomach problems such as heartburn • you have asthma Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • under a doctor’s care for any serious condition • taking any other drug When using this product • take with food or milk if stomach upset occurs Stop use and ask a doctor if 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 • symptoms do not improve • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • ringing in the ears or loss of hearing occurs • redness or swelling is present in the painful area • any new symptoms appear If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin 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. Prompt 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.