FDA Label for Aspirin

Otc - Active Ingredient

Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose

Pain reliever

Indications And Usage

Uses

for the temporary relief of minor aches and pains due to

• headache
• colds
• menstrual pain
• muscle pain
• toothache
• minor pain of arthritis

or as directed by your doctor

Warnings

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
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Otc - Do Not Use

Do not use

• if you are allergic to aspirin or any other pain reliever/fever reducer

Otc - Ask Doctor

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have asthma
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have not been drinking fluids
• you have lost a lot of fluid due to vomiting or diarrhea

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug
• under a doctor's care for any serious condition

Otc - Stop Use

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 painfull area

any new symptoms appear

ringing in the ears or a loss of hearing occurs

Otc - Pregnancy Or Breast Feeding

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 casue problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

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 last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
• children under 12 years: consult a doctor

Other Safety Information

Other information

• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

Inactive Ingredient

Inactive ingredientscorn starch, croscramellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Principal Display Panel

heb-aspirin-500s-label - heb aspirin 500s label