Drugplain

ASPIRIN 81 mg/1

ASPIRIN · TABLET, COATED · Kroger Company

10 Recalls on Record
Plain English

ASPIRIN is a tablet, coated containing aspirin at 81 mg/1, taken oral. Manufactured by Kroger Company.

Key Facts

Brand Name
ASPIRIN
Generic Name
ASPIRIN
NDC Code (Product)
41226-481
Manufacturer
Kroger Company
Strength
81 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
04/10/2021

Recall History

10 Recalls on Record
Class II06/06/2013

Novartis Consumer Health

Defective container: products are packaged in pouches which may not have been fully sealed

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: TRI-BUFFERED ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as the following drug: ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: W003596, EXP: 5/31/2014.

TerminatedVoluntary: Firm initiated
Class I03/02/2021

A-S Medication Solutions LLC.

Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.

TerminatedVoluntary: Firm initiated
Class II03/30/2017

Bayer HealthCare Pharmaceuticals, Inc.

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

TerminatedVoluntary: Firm initiated
Class II07/18/2012

LNK International, Inc.

Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.

TerminatedVoluntary: Firm initiated
Class III10/13/2021

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class III06/25/2019

AAA Pharmaceutical, Inc.

Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue49,959 reports
nausea42,007 reports
dyspnoea39,949 reports
off label use39,246 reports
drug ineffective38,456 reports
diarrhoea37,988 reports
headache34,301 reports
pain33,969 reports
dizziness30,787 reports
vomiting28,454 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 ASPIRIN used for?

ASPIRIN contains ASPIRIN. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is ASPIRIN a controlled substance?

ASPIRIN is not classified as a controlled substance by the DEA.

What is the generic name for ASPIRIN?

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

What is the NDC code for ASPIRIN 81 mg/1?

The NDC (National Drug Code) for ASPIRIN 81 mg/1 is 41226-481, listed by Kroger Company.