Aspirin

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)

Brand name
Aspirin
Generic name
ASPIRIN
Manufacturer
Trifecta Pharmaceuticals USA LLC
Product type
HUMAN OTC DRUG
SPL set ID
227cefca-acc4-41d0-e063-6394a90a35b9
SPL ID
55f653d0-d7f6-cae2-e063-6294a90acfa9
Version
5
Effective date
2026-07-06
Source export date
2026-09-28
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:40:13
Harmonized routes table
Harmonized routes
ORAL

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 behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a reare but serious illness. Allergy Alert Aspirin may cause severe allergic reaction, which may include, facial swelling, hives, shock, asthma (wheezing). Stomach bleeding warning This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you Have had stomach ulcers or bleeding problems Take blood thinning (anticogulant) or steroid drug Are age 60 or older take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others) Take more or for a longer time than directed Have 3 or more alcoholic drinks every day while using this product

Reported adverse events (FAERS/openFDA)#

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