Regular Strength Enteric Coated Aspirin
FDA Label NDC 80136-921

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Northeast Pharma for the product Regular Strength Enteric Coated Aspirin (NDC 80136-921). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin

Directions

  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • do not exceed recommended dose
  • adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

* Please review the disclaimer below.