Aspirin is an over-the-counter medicine (Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Drug class
- Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
- Taken
- Oral
- Label
- Strategic Sourcing Services LLC, revised September 9, 2026 · full label on DailyMed
Purpose
Pain reliever
What it is used for
for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin
Active ingredient
Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug
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 his product or any of its ingredients
Ask a doctor before use if you have
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 are taking a diuretic you have asthma
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: feel faint vomit blood have bloody or black stool have stomach pain that does not get better pain gets worse or lasts more than 10 days fever get worse or lasts more than 3 days redness or swelling is present ringing in the ears or loss of hearing occurs new symptoms occur These could be signs of a serious condition
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: 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 his 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 are taking a diuretic you have asthma 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: feel faint vomit blood have bloody or black stool have stomach pain that does not get better pain gets worse or lasts more than 10 days fever get worse or lasts more than 3 days redness or swelling is present ringing in the ears or loss of hearing occurs 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 at during the last 3 month 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at during the last 3 month 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
. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Aspirin in the news
We have not covered this medicine yet. Latest news
Products being discontinued
| Product | Availability | Expected supply / notes |
|---|---|---|
| Aspirin, Suppository, 300 mg (NDC 0574-7034-12) Padagis US LLC |
Discontinuation of the manufacture of the drug Being discontinued · July 23, 2026 |
Recalls
-
Class II Ongoing
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Lots, distribution and details
- Lots / codes
- Lot# 24A0061, exp. date 05/23/2026
- Distribution
- USA nationwide.
- Quantity
- 1470 boxes
- Recall started
- November 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0058-2025
-
Class II Terminated
Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Lots / codes
- Batch P126201
- Distribution
- Nationwide USA
- Quantity
- 2 units
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0170-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Aspirin
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 7ce4807e-7bd5-41f1-a9c7-1f3af6acdc09.