FDA Label for Aspirin Low Dose

Active Ingredient (In Each Tablet)

Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommended 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
• shock
• asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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

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 have asthma
• you are taking a diuretic

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

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

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.

Directions

• 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: ask a doctor

Other Information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive Ingredients

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

1-800-426-9391

How Supplied

Product: 71335-0622

NDC: 71335-0622-4 20 TABLET, COATED in a BOTTLE

NDC: 71335-0622-7 36 TABLET, COATED in a BOTTLE

NDC: 71335-0622-1 120 TABLET, COATED in a BOTTLE

NDC: 71335-0622-2 30 TABLET, COATED in a BOTTLE

NDC: 71335-0622-5 90 TABLET, COATED in a BOTTLE

NDC: 71335-0622-6 60 TABLET, COATED in a BOTTLE

NDC: 71335-0622-3 100 TABLET, COATED in a BOTTLE