FDA Label for Aspirin

Otc - Active Ingredient

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Pain reliever

Indications And Usage

• for the temporary relief of minor aches and pains or as recommended by your doctor.

• Because of its delayed release action, this product will not provide fast relief of headaches 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 everyday while using this product
• take more or for a longer time than directed

Otc - Do Not Use

If you are allergic to aspirin or any other pain reliever/fever reducer.

Otc - 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

Otc - Ask A Doctor/Pharmacist Before Use If You Are

taking a prescription drug for:

• Gout
• Diabetes
• arthritis

Otc - Stop Use And Ask A Doctor If

• 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
• allergic reaction occurs. Seek medical help right away.
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• new symptoms occur
• ringing in the ears or loss of hearing occurs

Otc - 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. 

Otc - Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage And Administration

• 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 15°-30°C (59°-86°F)
• do not use if seal on the carton is missing or damaged

Inactive Ingredient

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil,  polyethylene glycol, propylene glycol, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.