TRI-BUFFERED ASPIRIN- aspirin tablet, film coated 
Major Pharmaceuticals

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Major 44-183

Active ingredient (in each tablet)

Buffered aspirin equal to 325 mg aspirin (NSAID)*
(buffered with calcium carbonate, magnesium carbonate, and magnesium oxide)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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:

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

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

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

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

  • 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
  • ringing in the ears or a 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
  • new symptoms occur

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 at 20 weeks or later in 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

Other information

Inactive ingredients

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

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-2015-59

Compare to the active
ingredient in BUFFERIN®

TRI-BUFFERED
ASPIRIN

325 mg

pain reliever/fever reducer (NSAID)

100 TABLETS

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

This product is not manufactured or distributed by Genomma
Lab USA, Inc., owner of the registered trademark Bufferin®.
50844            REV0122N18312
Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152  USA           M-17
Re-order No. 700594       Rev. 07/18

Major 44-183

Major 44-183

TRI-BUFFERED ASPIRIN 
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE 410 (UNII: TYU5GP6XGE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;183
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-2015-591 in 1 CARTON03/30/1990
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/30/1990
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(0904-2015)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(0904-2015)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(0904-2015)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(0904-2015)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(0904-2015)

Revised: 4/2024
Document Id: e63a93bb-55fd-4137-8699-dcc07d2ffb5a
Set id: 5cefc706-4930-40e5-bca1-19f03420a362
Version: 17
Effective Time: 20240417
 
Major Pharmaceuticals