FDA Label for Bayer Aspirin

Active Ingredient (In Each Tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves
• headache • muscle pain • toothache

• menstrual pain • pain and fever of colds • minor pain of arthritis

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

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
• redness or swelling is present
• fever lasts more than 3 days
• new symptoms occur
• 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 problems 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 1 or 2 tablets every 4 hours or 3 tablets

every 6 hours, not to exceed 12 tablets in 24 hours
• children under 12 years: consult a doctor

Other Information

• save carton for full directions and warnings
• store at room temperature

Inactive Ingredients

carnauba wax*,corn starch, hypromellose, powdered cellulose, triacetin

*may contain this ingredient

Questions Or Comments?

1-800-331-4536 (Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

Package Labeling:

Package Label - Bayer 50