Aspirin Tablet
FDA Label NDC 50332-0139

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hart Health for the product Aspirin (NDC 50332-0139). 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, purpose, uses, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Aspirin (NSAID)* 325mg (*non-steroidal anti-inflammatory drug)

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • backache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothache
  • menstrual cramps

    • Temporarily reduces fever

Warnings

Reye's Syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin

Allergy altert: Aspirin may cause a several 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 ulers or bleeding problems
    • take more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, others)
    • have 3 or more alcholic drinks every day while using this product

* Please review the disclaimer below.