Aspirin Low Dose

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 Low Dose
Generic name
ASPIRIN
Manufacturer
Preferred Pharmaceuticals Inc.
Product type
HUMAN OTC DRUG
SPL set ID
994fca33-7720-44bf-8db8-ce561d626189
SPL ID
6ddddaca-9072-417b-b4db-cb5e376963d6
Version
5
Effective date
2026-03-06
Source export date
2026-08-01
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:15:35
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 • shock • asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • take more or for a longer time than directed • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have had stomach ulcers or bleeding problems • have 3 or more alcoholic drinks every day while using this product • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older 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 asthma • you have a history of stomach problems, such as heartburn • you are taking a diuretic • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease 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: o vomit blood o have bloody or black stools o feel faint o have stomach pain that does not get better • ringing in the ears or a loss of hearing occurs • new symptoms occur • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present 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 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.