TRI-BUFFERED ASPIRIN- aspirin tablet, film coated 
Proficient Rx LP

----------

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

temporarily relieves minor aches and pains associated with:
o
toothache
o
minor pain of arthritis
o
backache
o
the common cold
o
headache
o
muscular aches
o
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:
o
feel faint
o
vomit blood
o
have bloody or black stools
o
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

NDC 71205-517-30

Compare to the active ingredient in BUFFERIN®†

TRI-BUFFERED
ASPIRIN
325 mg

pain reliever/fever reducer (NSAID)

30 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 

Repackaged by Proficient Rx LP
Thousand Oaks, CA 91320 

   
M-17
Re-order No. 700594    Rev. 07/18

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

71205-517-30
TRI-BUFFERED ASPIRIN 
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-517(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)  
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
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;183
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-517-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2020
2NDC:71205-517-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2020
3NDC:71205-517-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/30/1990
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-517) , RELABEL(71205-517)

Revised: 10/2023
Document Id: ccda47aa-2aeb-4e29-b140-bb903d516bbf
Set id: 640c3311-2abf-40b2-82b9-9fe4d8c1cf1d
Version: 4
Effective Time: 20231001
 
Proficient Rx LP