TRI-BUFFERED ASPIRIN- aspirin tablet, film coated

Tri-Buffered Aspirin by

Drug Labeling and Warnings

Tri-Buffered Aspirin by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• temporarily relieves minor aches and pains associated with:
  • toothache
  • minor pain of arthritis
  • backache
  • the common cold
    
  • headache
  • muscular aches
    
  • 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

• have had stomach ulcers or bleeding problems
• have 3 or more alcoholic drinks every day while using this product
• 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]
• 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
• 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
• arthritis
• diabetes

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 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 (1-800-222-1222) right away.

Directions

• drink a full glass of water with each dose
• adults and children 12 years and over: take 2 tablets every 4 hours not to 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

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

†This product is not manufactured or distributed by Dr. Reddy's Laboratories Inc., owner of the registered trademark Bufferin®.
50844     REV0318M18312

Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233 
Livonia, MI 48152 USA    
M-17
Re-order No. 700594    Rev. 07/18

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

Major 44-183

INGREDIENTS AND APPEARANCE

TRI-BUFFERED ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-2015
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DIMETHICONE 410 (UNII: TYU5GP6XGE)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;183
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-2015-59	1 in 1 CARTON	03/30/1990
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	03/30/1990

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0904-2015)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0904-2015)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(0904-2015)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0904-2015)