Drugplain

Low Dose Aspirin 81 mg/1

ASPIRIN · TABLET, CHEWABLE · WinCo Foods, LLC

2 Recalls on Record
Plain English

Low-dose aspirin is an over-the-counter nonsteroidal anti-inflammatory drug commonly used to help prevent heart attacks and strokes in people at risk for these conditions. It is available as an 81 mg oral tablet that can be swallowed or chewed.

Key Facts

Brand Name
Low Dose Aspirin
Generic Name
ASPIRIN
NDC Code (Product)
67091-389
Manufacturer
WinCo Foods, LLC
Strength
81 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
08/30/2021

Recall History

2 Recalls on Record
Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated
Class III11/10/2017

Bayer HealthCare Pharmaceuticals, Inc.

Failed Stability Specifications

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue31,291 reports
dyspnoea26,708 reports
nausea25,997 reports
diarrhoea25,805 reports
dizziness21,958 reports
drug ineffective20,916 reports
headache19,131 reports
asthenia18,449 reports
off label use18,192 reports
fall18,171 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses 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

Dosage & Administration

Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

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: 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 proble…

Frequently Asked Questions

What is Low Dose Aspirin used for?

Low-dose aspirin is an over-the-counter nonsteroidal anti-inflammatory drug commonly used to help prevent heart attacks and strokes in people at risk for these conditions. It is available as an 81 mg oral tablet that can be swallowed or chewed.

Is Low Dose Aspirin a controlled substance?

Low Dose Aspirin is not classified as a controlled substance by the DEA.

What is the generic name for Low Dose Aspirin?

The generic name for Low Dose Aspirin is ASPIRIN. There are 11 other brand versions of ASPIRIN.

What is the NDC code for Low Dose Aspirin 81 mg/1?

The NDC (National Drug Code) for Low Dose Aspirin 81 mg/1 is 67091-389, listed by WinCo Foods, LLC.

Product NDC

67091-389

Package NDC

67091-389-36

Other Low Dose Aspirin Dosages

Other Aspirin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)