Drugplain

Aspirin NSAID 325 mg/1

Aspirin · TABLET, FILM COATED · Valu Merchandisers Company

9 Recalls on Record
Plain English

Aspirin NSAID is a tablet, film coated containing aspirin at 325 mg/1, taken oral. Manufactured by Valu Merchandisers Company.

Key Facts

Brand Name
Aspirin NSAID
Generic Name
Aspirin
NDC Code (Product)
63941-157
Manufacturer
Valu Merchandisers Company
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
02/10/1996

Recall History

9 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 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 I07/11/2024

Aurobindo Pharma USA Inc

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

OngoingVoluntary: 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 II02/16/2017

Allegiant Health

cGMP deviations - presence of rubber particles found loose in the bulk product.

TerminatedVoluntary: Firm initiated
Class II12/06/2021

Medique Products

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
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 II12/06/2021

Medique Products

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class I06/17/2013

Advance Pharmaceutical Inc

Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue31,110 reports
dyspnoea26,618 reports
nausea25,851 reports
diarrhoea25,656 reports
dizziness21,845 reports
drug ineffective20,815 reports
headache19,018 reports
asthenia18,354 reports
off label use18,133 reports
fall18,117 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves: headache pain and fever of colds toothache menstrual pain muscle pain minor pain of arthritis

Dosage & Administration

Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by 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: shock facial swelling hives 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 this 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,

Frequently Asked Questions

What is Aspirin NSAID used for?

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

Is Aspirin NSAID a controlled substance?

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

What is the generic name for Aspirin NSAID?

The generic name for Aspirin NSAID is Aspirin. There are 12 other brand versions of Aspirin.

What is the NDC code for Aspirin NSAID 325 mg/1?

The NDC (National Drug Code) for Aspirin NSAID 325 mg/1 is 63941-157, listed by Valu Merchandisers Company.