FDA Label for Extra Strength Aspirin

Drug Facts

Purpose

Pain reliever/ Fever reducer

Active Ingredient (In Each Tablet)

Aspirin 325mg

Uses

Temporarily relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps

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 behaviour 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 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

• you have asthma
• 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

Ask A Doctor Or Pharmacist Before Use If You Are

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

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

2. an allergic reaction occurs.

• seek medical help right away.

3. ringing in the ears or loss of hearing occurs

4. pain gets worse or lasts for more than 3 days

5. redness or swelling present

6. new symptoms occur

These could be sign of a serious condition.

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• Do not take more than directed
• Drink a full glass of water with each dose
• Adults and children 12 years of age 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
• do not use for more than 10 days unless directed by a doctor
• Children under 12 years: do not use unless directed by a doctor

Other Information

• Store at controlled room temperature 25°C (77°F) excursions permitted between 15-30°C (59-86°F)

Inactive Ingredients

• Corn starch
• Carnauba Wax
• Hypromellose
• Polyethylene Glycol
• Povidone
• Talc
• Titanium dioxide

Questions Or Comments?

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