Tri-Buffered Aspirin

Dosage form: tablet, film coated
Ingredients: ASPIRIN 325mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-2015

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Major 44-183

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

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

TRI-BUFFERED ASPIRIN 
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2015
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
DIMETHICONE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;183
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-2015-591 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
1100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/30/1990
Labeler - Major Pharmaceuticals (191427277)

Revised: 04/2011
 
Major Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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