LOW DOSE ASPIRIN- aspirin tablet, coated 
Proficient Rx LP

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Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever 

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for safety coated 81 mg aspirin

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

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 stool
o
have stomach pain that does not get better
pain gets worse or lasts more than 10 days
redness or swelling is present 
ringing in the ears or loss of hearing occurs
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 right away (1-800-222-1222).

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: do not use

Other information

store between 15-30ºC (59-86ºF)

Inactive ingredients

anhydrous lactose**, black iron oxide**, brown iron oxide**, corn starch**, croscarmellose sodium**, D&C yellow #10, FD&C yellow #6**, hypromellose**, methacrylic acid copolymer, microcrystalline cellulose, mineral oil**, pharmaceutical ink**, polysorbate 80**,  potassium hydroxide**, propylene glycol**, purified water**, shellac**, silicon dioxide, simethicone**, sodium bicarbonate**, sodium hydroxide**, sodium lauryl sulfate**, stearic acid**, talc, titanium dioxide, triethyl citrate, yellow iron oxide**

**contains one or more of these ingredients 

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to the active ingredient in Bayer® Low Dose Aspirin

Aspirin 81 mg

Low Dose

Pain reliever (NSAID)

Aspirin regimen±

Enteric Coated±±

Safety coated

This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.

≠≠Coating helps protect against stomach upset

Talk to your doctor or other healthcare provider before using this product for your heart.Aspirin is not right for everyone.

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

Distributed by:

Major® Pharmaceuticals

17177 N Laurel Park Drive,

Suite, Livonia MI 48152

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Product Label

71205-328-72

Aspirin 81 mg Low Dose

LOW DOSE ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-328(NDC:0904-6713)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint Code E;T81;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-328-72120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201902/28/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01302/28/201802/28/2025
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-328) , RELABEL(71205-328)

Revised: 1/2024
Document Id: 8e5dd88c-96bd-4eec-be78-0daf9db359f1
Set id: 74721551-474a-4165-abda-ce30a721226b
Version: 3
Effective Time: 20240101
 
Proficient Rx LP