Drugplain

Adult Low Dose Aspirin Enteric Coated 81 mg/1

Aspirin 81mg · TABLET, DELAYED RELEASE · Pharbest Pharmaceuticals, Inc.

No Recall History
Plain English

Adult Low Dose Aspirin Enteric Coated is a tablet, delayed release containing aspirin 81mg at 81 mg/1, taken oral. Manufactured by Pharbest Pharmaceuticals, Inc..

Key Facts

Brand Name
Adult Low Dose Aspirin Enteric Coated
Generic Name
Aspirin 81mg
NDC Code (Product)
16103-351
Manufacturer
Pharbest Pharmaceuticals, Inc.
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
02/20/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

death40 reports
fatigue33 reports
anaemia30 reports
nausea30 reports
disease progression27 reports
headache26 reports
vomiting26 reports
diarrhoea23 reports
haemorrhage23 reports
dizziness21 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 headache 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 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, s

Frequently Asked Questions

What is Adult Low Dose Aspirin Enteric Coated used for?

Adult Low Dose Aspirin Enteric Coated contains Aspirin 81mg. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is Adult Low Dose Aspirin Enteric Coated a controlled substance?

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

What is the generic name for Adult Low Dose Aspirin Enteric Coated?

The generic name for Adult Low Dose Aspirin Enteric Coated is Aspirin 81mg. There are 4 other brand versions of Aspirin 81mg.

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

The NDC (National Drug Code) for Adult Low Dose Aspirin Enteric Coated 81 mg/1 is 16103-351, listed by Pharbest Pharmaceuticals, Inc..

Product NDC

16103-351

Package NDC

16103-351-09

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

Data from openFDA · Public domain (CC0 1.0)