ASPIRIN DELAYED RELEASE 81MG

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 DELAYED RELEASE 81MG
Generic name
ASPIRIN DELAYED RELEASE 81MG
Manufacturer
Farmacias De Similares TX LLC
Product type
HUMAN OTC DRUG
SPL set ID
3a8a3efc-f0b3-411c-e063-6394a90a84b7
SPL ID
4849b3d5-5bae-89a4-e063-6394a90aef56
Version
2
Effective date
2026-01-13
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:59
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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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 . shock . facial swelling . asthma (wheezing) 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 you are allergic to aspirin, or any other pain reliever/fever reducer . if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if . Stomach bleeding warning applies to you . You have a history of stomach problems, such as heartburn . You have high blood pressure, heart disease, liver cirrhosis, or kidney disease . You have asthma . You are taking a diuretic Ask a doctor or pharmacist before use if you are Taking a prescription drug for . gout . diabetes . 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: -Vomit blood -Have bloody or black stools -Feel faint -Have stomach pain that does not get better . Ringing in the ears or a loss of hearing occurs . Pain gets worse or lasts more than 10 days . Fever gets worse or lasts more than 3 days . Redness or swelling is present . New symptoms occur These could 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 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. Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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.