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
Richmond Pharmaceuticals, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
6a4c897d-c2a8-41b8-98b7-e7da8e2819ec
SPL ID
5cc44dca-00c9-b589-e053-2a91aa0a0521
Version
2
Effective date
2017-10-30
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:52:52
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 behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early signs of Reye’s syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include hives asthma (wheezing) shock facial swelling Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child has had stomach ulcers or bleeding problems take a blood-thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others) takes more or for a longer time than directed Do not use if the child has ever had an allergic reaction to any other pain reliever / fever reducer for at least 7 days after tonsillectomy or oral surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has not been drinking fluids child has lost a lot of fluid due to vomiting and diarrhea child has high blood pressure, heart disease, lever cirrhosis, or kidney disease child is taking a diuretic child has asthma Ask a doctor or pharmacist before use if the child is taking a prescription drug for diabetes, gout or arthritis taking any other drug under a doctor’s care for any serious condition Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better pain gets worse or lasts more than 5 days any new symptoms appear redness or swelling is present in the painful area ringing in the ears or a loss of hearing occurs If pregnant or breast-feeding, ask a health 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.

Reported adverse events (FAERS/openFDA)#

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