Aspirina Caplets

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
Aspirina Caplets
Generic name
ASPIRIN
Manufacturer
Bayer HealthCare LLC.
Product type
HUMAN OTC DRUG
SPL set ID
2e6f5ba8-8e8b-6059-e063-6394a90adcd5
SPL ID
2e6f5ba8-8e8c-6059-e063-6394a90adcd5
Version
1
Effective date
2025-02-18
Source export date
2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:37:23
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/Advertencias 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 sign of Reye’s syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warni ng: 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 Síndrome de Reye : Los niños y adolescentes que tienen varicela, o se están recuperando de ella o tienen síntomas parecidos a los de la gripe, no deben usar este producto. Cuando se utiliza este producto, si se producen cambios en la conducta y se presentan náuseas y vómitos, consulte a un médico porque estos síntomas podrían ser un signo temprano del síndrome de Reye, una enfermedad rara pero grave. Alerta de alergia : La aspirina puede provocar una reacción alérgica grave que puede incluir: urticaria edema facial asma (sibilancia) choque Advertencia de sangrado estomacal : Este producto contiene un fármaco antiinflamatorio no esteroideo (AINE), que puede causar una grave hemorragia estomacal. Las posibilidades son mayores si usted tiene 60 años o más ha tenido úlceras estomacales o problemas de sangrado toma un anticoagulante o un medicamento esteroideo toma otros medicamentos que contienen antiinflamatorios no esteroideos (AINE) con o sin receta (aspirina, ibuprofeno, naproxeno u otros) toma 3 o más bebidas alcohólicas todos los días mientras usa este producto toma más o por más tiempo de lo indicado

Reported adverse events (FAERS/openFDA)#

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