Cvs 44-645

Cvs 44-645
SPL v18
SPL
SPL Set ID 6e1c1129-562b-4a8a-ac37-db3cb2a82735
Route
ORAL
Published
Effective Date 2026-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromellose, Unspecified Methacrylic Acid Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Shellac Dimethicone Water Sodium Bicarbonate Sodium Lauryl Sulfate Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: L Shape: round Color: pink Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-07-25 Until 2027-05-31

Description

Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever 


Medication Information

Purpose

Pain reliever 

Description

Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug 

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.

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

  • take a blood thinning (anticoagulant) or steroid drug

  • have had stomach ulcers or bleeding problems

  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
Directions
  • do not take more than directed

  • 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 unless directed by a doctor

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
Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredients

colloidal anhydrous silica, corn starch, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate



Questions Or Comments?

1-800-426-9391 

Principal Display Panel

VALUE SIZE

365

TABLETS

♥CVS

Health®

Compare to the active ingredient in St. Joseph®

Low Dose Safety Coated 81 mg Aspirin

Coated Tablets

Low Strength

Aspirin

Pain reliever (NSAID)

81

mg

Talk to your doctor or

other healthcare provider

before using this product

for your heart.

Actual Size

Safety Coated

365 ENTERIC COATED TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY 

SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC,

owner of the registered trademark St. Joseph® Low Dose Safety Coated 81 mg Aspirin.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-11112

50844   REV0122B64551

CVS 44-645
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
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:
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • feel faint

  • 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.

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

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.

Purpose

Pain reliever 

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

  • take a blood thinning (anticoagulant) or steroid drug

  • have had stomach ulcers or bleeding problems

  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
Directions
  • do not take more than directed

  • 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 unless directed by a doctor

Do Not Use (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
Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredients (Inactive ingredients)

colloidal anhydrous silica, corn starch, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate



Questions Or Comments? (Questions or comments?)

1-800-426-9391 

Principal Display Panel

VALUE SIZE

365

TABLETS

♥CVS

Health®

Compare to the active ingredient in St. Joseph®

Low Dose Safety Coated 81 mg Aspirin

Coated Tablets

Low Strength

Aspirin

Pain reliever (NSAID)

81

mg

Talk to your doctor or

other healthcare provider

before using this product

for your heart.

Actual Size

Safety Coated

365 ENTERIC COATED TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY 

SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC,

owner of the registered trademark St. Joseph® Low Dose Safety Coated 81 mg Aspirin.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-11112

50844   REV0122B64551

CVS 44-645
Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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:
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • feel faint

  • 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, (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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)