FDA Label for Aspirin

View Indications, Usage & Precautions

Aspirin Product Label

The following document was submitted to the FDA by the labeler of this product Hart Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.