Aspirin Enteric Safety Coated 81 mg/1

Aspirin · TABLET · Publix Supermarkets, Inc.

1 Recall on Record

Plain English

Aspirin Enteric Safety Coated is a tablet containing aspirin at 81 mg/1, taken oral. Manufactured by Publix Supermarkets, Inc..

Key Facts

Brand Name: Aspirin Enteric Safety Coated
Generic Name: Aspirin
NDC Code (Product): 56062-867
Manufacturer: Publix Supermarkets, Inc.
Strength: 81 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: M013
Drug Class: Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start: 07/31/2019

Recall History

1 Recall on Record

Class II09/15/2014

American Family Pharmacy, LLC

Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue31,252 reports

dyspnoea26,682 reports

nausea25,961 reports

diarrhoea25,775 reports

dizziness21,932 reports

drug ineffective20,893 reports

headache19,097 reports

asthenia18,423 reports

off label use18,184 reports

fall18,150 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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 have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Frequently Asked Questions

What is Aspirin Enteric Safety Coated used for?

Aspirin Enteric Safety Coated contains Aspirin. It is a tablet taken oral. Consult your doctor for specific uses.

Is Aspirin Enteric Safety Coated a controlled substance?

Aspirin Enteric Safety Coated is not classified as a controlled substance by the DEA.

What is the generic name for Aspirin Enteric Safety Coated?

The generic name for Aspirin Enteric Safety Coated is Aspirin. There are 12 other brand versions of Aspirin.

What is the NDC code for Aspirin Enteric Safety Coated 81 mg/1?

The NDC (National Drug Code) for Aspirin Enteric Safety Coated 81 mg/1 is 56062-867, listed by Publix Supermarkets, Inc..

Product NDC

56062-867

Package NDC

56062-867-12

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)