ASPIRIN 81MG TABLETS

SPL UNCLASSIFIED SECTION

Drug Fact

Active ingredient (in each tablet)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

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 useif 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 · Fever gets worse or lasts more than 3 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:

Corn Starch, Pregelatinized Starch, Povidone, Microcrystalline Cellulose, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, Silica, Sodium bicarbonate, Sodium lauryl sulfate, D&C Yellow #10, Hypromellose, Triacetin

Questions?

Adverse Drug Event Call: (888) 582 1953or Email: drugsafety@marlexpharm.com