Aspirin 81mg Enteric Coated Tablet, Delayed Release
FDA Label NDC 77333-031

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Aspirin 81mg Enteric Coated (NDC 77333-031). 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, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Aspirin 81mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Uses

  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headache or other symptoms needing immediate relief.

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
  • 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 ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

Do Not Use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for:

  • gout
  • diabetes
  • arthritis

Stop Use And Ask A Doctor If

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over:take 4 to 8 tablets every 4 hours; not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years:consult a doctor

Other Information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

Acrycoat, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow# 10, Lactose, Microcrystalline Cellulose, Polysorbate 80, Sodium Hydroxide, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Oxide of Iron.

* Please review the disclaimer below.