Tri-Buffered Aspirin

Major Pharmaceuticals

Major 44-183

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient(s)
• Purpose
• Use(s)
• 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
• Tri-Buffered Aspirin Other information
• Inactive ingredients
• Questions
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient(s)

Buffered aspirin equal to 325 mg aspirin (NSAID)*.

(buffered with magnesium carbonate, calcium carbonate and magnesium oxide)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Use(s)

• temporarily relieves minor aches and pains associated with:

• muscular aches backache

• headache

• minor pain of arthritis

• backache

• toothache

• the common cold

• premenstrual & menstrual cramps

• temporarily reduces fever

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

• 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

• 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

• vomit blood

• have bloody or black stools

• have stomach pain that does not get better

• an allergic reaction occurs

• symptoms do not improve

• new symptoms occur

• ringing in the ears or loss of hearing occurs

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 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

• adults and children 12 years and over: 2 tablets with a full glass of water. Dosage may be repeated every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless directed by a doctor.

• children under 12 years: do not use unless directed by a doctor

Tri-Buffered Aspirin Other information

• each tablet contains: calcium 35 mg and magnesium 40 mg

• store at controlled room temperature 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive ingredients

citric acid, corn starch, dibasic sodium phosphate, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide

Questions

To Report Adverse Drug Event Call: 1-800-426-9391

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

MAJOR®

See New Warnings Information

NDC 0904-2015-59

TRI-BUFFERED

ASPIRIN

PAIN RELIEF

pain reliever/fever reducer (NSAID)

100 TABLETS • 325 mg

Compare to the active ingredient in BUFFERIN®

Distributed by MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI 48150 USA    M-17

Re-Order No. 700594    Rev. 11/10

TAMPER EVIDENT: DO NO USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844    REV1110H18312