FDA Label for Aspirin 81 Mg Enteric Coated

Purpose

Aspirin 81 mg Tablets

Uses

• Temporarily relieves minor aches and pains.
  
• For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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
  
• 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

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
  
• You have not been drinking fluids
  
• You have lost a lot of fluid due to vomiting or diarrhea

Ask A Doctor Or A Pharmacist Before Use If You Are

• Taking a prescription drug for diabetes, gout, or arthritis
  
• Under a doctor’s care for any serious condition
  
• Taking any other drug

Stop Use And Ask A Doctor If

• You experience any of the following signs of stomach bleeding
  
• Feel faint
  
• Have bloody or black stools
  
• Vomit blood
  
• Have stomach pain that does not get better
  
• Pain gets worse or lasts more than 10 days
  
• Redness or swelling is present in the painful area
  
• Any new symptoms appear
  
• Ringing in the ears or a loss of hearing occurs

If Pregnant Or Breast-Feeding

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problem in the unborn child or complications during delivery.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center 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)
  
• Use by expiration date on package

Inactive Ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized Starch, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl Acrylate Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6

Questions?

Adverse Drug Event Call: (800) 222-1222

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 12/19 HP

Principal Display Panel

ASPIRIN
81mg
120 Tablets

PRINCIPAL DISPLAY PANELASPIRIN81mg120 Tablets - aspirin 81mg enteric coated tablets 01