FDA Label for Aspirin

Active Ingredient (In Each Tablet)

Aspirin 325mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Indications & Usage

• Temporarily relieves minor aches and pains due to • colds • headache • muscle pain • menstrual pain • minor pains of arthritis • toothache
• or as receommended by your doctor

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• take more or for a longer time than directed
• have had stomach ulcers or bleeding problems
• have 3 or more alcoholic drinks every day while using this product

Do Not Use

if you have ever had an allergic reaction 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 are taking a diuretic
• you have asthma
• you have high blood pressure, heart disease, liver cirrhosis or kidney disease

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 
• any new symptoms occur 
• ringing in the ears or loss of hearing occurs 
 These could be signs of a serious illness.

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 accidental 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 to 2 tablets every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless diretced by a physician.
children under 12 years	consult a physician

Other Information

• avoid excess heat and moisture
• store below 25⁰ C (77⁰ F)

Inactive Ingredients

croscarmellose sodium, D&C yellow #10 Lake, FD&C red #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin. 

Questions Or Comments?

Adverse drug event call: 1-866-562-2756 

Package Label.Principal Display Panel

^†Compare to Ecotrin^® active ingredient

Leader 

Regular Strength Aspirin

Enteric Coated Aspirin 325 mg

Pain Reliever (NSAID)