Aspirin

Cardinal Health

Leader 44-218-SJ

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Aspirin Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Aspirin Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

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

Purpose

Pain reliever

Aspirin 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:

• have had stomach ulcers or bleeding problems

• 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]

• 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 have ever had an allergic reaction to any pain reliever or fever reducer

• for at least 7 days after tonsillectomy or oral surgery unless directed by a 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 high blood pressure, heart disease, liver cirrhosis or kidney disease
• you have asthma

• user takes 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

• 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

These could be signs 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 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 while symptoms persist.  Do not exceed 48 tablets in 24 hours or as directed by a doctor.
• children under 12: do not use unless directed by  a doctor

Aspirin Other information

• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive ingredients

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange enhancer, orange flavor, sodium saccharin

Principal Display Panel

NDC 37205-369-68

LEADER®

Compare to St. Joseph® active ingredient†

Aspirin
Pain reliever (NSAID)
81 mg Chewable
Adult Low Strength Aspirin Regimen

Orange Flavored

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844    REV0512G21807

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

CIN 3510955