Regular Strength Enteric Coated Aspirin
FDA Label NDC 50090-4462

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Regular Strength Enteric Coated Aspirin (NDC 50090-4462). 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.

Active Ingredient (In Each Tablet)

Aspirin 325 mg(NSAID)*

*nonsteroidal anti-inflammatory drug

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

Other Information

  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only

How Supplied

Product: 50090-4462

NDC: 50090-4462-1 30 TABLET, COATED in a BOTTLE

NDC: 50090-4462-3 100 TABLET, COATED in a BOTTLE

NDC: 50090-4462-5 90 TABLET, COATED in a BOTTLE

* Please review the disclaimer below.