Aspirin Tablet, Coated
FDA Label NDC 37808-174

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H-e-b for the product Aspirin (NDC 37808-174). 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 otc - active ingredient, otc - purpose, indications and usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose

Pain reliever

Indications And Usage

Uses

for the temporary relief of minor aches and pains due to

  • headache
  • colds
  • menstrual pain
  • muscle pain
  • toothache
  • minor pain of arthritis
  • or as directed by your 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
  • shock
  • asthma (wheezing)
  • 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
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

drink a full glass of water with each dose

  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Inactive Ingredient

Inactive ingredientscorn starch, croscramellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Principal Display Panel

Heb-aspirin-500s-label (Heb Aspirin 500s Label)

Heb-aspirin-500s-label (Heb Aspirin 500s Label)

Heb-aspirin-300s-label (Heb Aspirin 300s Label)

Heb-aspirin-300s-label (Heb Aspirin 300s Label)

Heb-aspirin-100s-label (Heb Aspirin 100s Label)

Heb-aspirin-100s-label (Heb Aspirin 100s Label)

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