Drugplain

Aspirin 81 MG 81 mg/1

ASPIRIN · TABLET, DELAYED RELEASE · VALU MERCHANDISERS COMPANY

2 Recalls on Record
Plain English

Aspirin 81 MG is a tablet, delayed release containing aspirin at 81 mg/1, taken oral. Manufactured by VALU MERCHANDISERS COMPANY.

Key Facts

Brand Name
Aspirin 81 MG
Generic Name
ASPIRIN
NDC Code (Product)
63941-080
Manufacturer
VALU MERCHANDISERS COMPANY
Strength
81 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
11/01/2023

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

fatigue31,178 reports
dyspnoea26,669 reports
nausea25,909 reports
diarrhoea25,706 reports
dizziness21,900 reports
drug ineffective20,849 reports
headache19,061 reports
asthenia18,405 reports
fall18,158 reports
off label use18,147 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 this product

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 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 you are allergic to aspirin or any other pain reliever/fever reducer 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 kid

Frequently Asked Questions

What is Aspirin 81 MG used for?

Aspirin 81 MG contains ASPIRIN. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is Aspirin 81 MG a controlled substance?

Aspirin 81 MG is not classified as a controlled substance by the DEA.

What is the generic name for Aspirin 81 MG?

The generic name for Aspirin 81 MG is ASPIRIN. There are 12 other brand versions of ASPIRIN.

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

The NDC (National Drug Code) for Aspirin 81 MG 81 mg/1 is 63941-080, listed by VALU MERCHANDISERS COMPANY.