LOW DOSE 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
LOW DOSE ASPIRIN
Generic name
ASPIRIN
Manufacturer
Pinnacle RX LLC
Product type
HUMAN OTC DRUG
SPL set ID
53c11fb4-ba31-b5e5-e063-6394a90a9c1a
SPL ID
53c127e2-7d69-bcd5-e063-6394a90a4689
Version
1
Effective date
2026-06-08
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:27:42
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 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 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 Do not use if your are allergic to aspirin or any other pain reliever/fever reducer. Ask a doctor before use if the stomach bleeding warning applies to you you are taking a diuretic you have a history of stomach problems, such as heartburn you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout or arthritis Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away 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 pain gets worse or lasts more than 10 days redness or swelling is present fever gets worse or lasts more than 3 days any new symptoms occur ringing in the ears or loss of hearing occurs These can be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. it is especially important not to use aspirin at 20 weeks or later in 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.

Reported adverse events (FAERS/openFDA)#

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