Aspirin

Cardinal Health

Major Pharmaceuticals Aspirin 81 mg Drug Facts

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,
  • Warning: Keep out of reach of children.
• Directions
• Aspirin Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Chewable

Low Dose

Orange Flavor

Aspirin Regimen**

Gluten Free

Purpose

Pain reliever

Aspirin Uses

for the temporary relief of minor aches and pains

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 every day while using this product
• ••take more or for a longer time than directed

**Aspirin is not appropriate for eveyone, so be sure to talk to you doctor before you begin and aspirin regimen.

Do not use

• ••if you have ever had an allergic reaction to any other pain reliever/fever reducer
• ••for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

• ••you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• ••stomach bleeding warning applies to you
• ••you have a history of stomach problems, such as heartburn
• ••you are taking a diuretic
• ••you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

• ••an allergic reaction occurs. Seek medical help right away.
• ••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
• ••pain gets worse or lasts for more than 10 days
• ••fever gets worse or lasts for more than 3 days
• ••redness or swelling is present
• ••new symptoms occur
• ••ringing in the ears or loss of hearing occurs

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.

Warning: Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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: consult a doctor

Aspirin Other information

• ••store at 20-25°C (68-77°F)

COMPARE TO the active ingredient of BAYER® CHEWABLE ASPIRIN ***

***Major® Aspirin 81 mg is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer Chewable A

Gluten Free

Bulk Manufacturer NDC 0904-4040-73

Inactive ingredients

corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium

Questions or comments?

1-800-616-2471

Distributed by

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

Rev. 11/11

Repackaged by Cardinal Health

Zanesville, OH 43701

IE70130713

Principal Display Panel

Aspirin

Pain Reliever (NSAID) tablets

81 mg

Contains Approximately 2052 Tablets