FDA.reportPublic FDA data

Low Dose Aspirin

Manufacturer
Walgreen Company | LNK International, Inc.
Effective date
2021-09-09
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 22:36:43

Label at a glance#

ProductLow Dose Aspirin
Active ingredientASPIRIN
Label structure8 sections

Indications and uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Dosage and administration

drink a full glass of water with each dose chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number 

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

 Pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains or as recommended by your doctor

Warnings

WARNINGS SECTION

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
  • have 3 or more alcoholic drinks every day while using this product
  • 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

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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
    • feel faint
    • 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
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.


If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, flavor, maltodextrin, sucralose

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE SIZE

NDC 0363-0397-07

Walgreens

Compare to Bayer® Chewable Low Dose Aspirin active ingredient††

Aspirin 81

81 mg CHEWABLE TABLETS
PAIN RELIEVER (NSAID)

CHEWABLE
LOW DOSE

HEART
HEALTH••

108
CHEWABLE
TABLETS
(3 BOTTLES: 36 TABLETS PER BOTTLE)

ACTUAL SIZE

CHERRY FLAVOR

Chew or crush tablets completely before swallowing. Do not swallow tablets whole.
**Talk to your doctor or other healthcare provider before using this product for your heart.

†Walgreens Pharmacist Survey
††This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.
50844      REV1118A39707

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

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
©2018 Walgreen Co.

44-397A
44-397A

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0397-07EA - Each0363-03973440cbab-62b1-4fd4-b00d-f44f1858d15912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E3
ASPIRINACTIVE MOIETYR16CO5Y76E3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808B3
DEXTRATESINACTIVE INGREDIENTG263MI44RU3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-03970363-0397-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 302S42T2808BIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
STARCH, CORNO8232NY3SJIACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 19 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii candidate
7 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii candidate
4 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET / ORAL437 mgExact identifier — unii candidate
8 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii candidate
4 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BCAPSULE / ORAL0.1 mgExact identifier — unii candidate
7 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, EXTENDED RELEASE / ORAL594 mgExact identifier — unii candidate
8 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii candidate
4 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
7 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RULOZENGE / TRANSMUCOSAL7360 mgExact identifier — unii candidate
8 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, ORALLY DISINTEGRATING / ORAL311 mgExact identifier — unii candidate
8 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, COATED / ORAL1.16 mgExact identifier — unii candidate
7 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE / ORAL3 mgExact identifier — unii candidate
7 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTROCHE / ORAL4505 mgExact identifier — unii candidate
8 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii candidate
8 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUPOWDER / ORAL2567 mgExact identifier — unii candidate
8 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, FILM COATED / ORAL0.26 mgExact identifier — unii candidate
7 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, DELAYED RELEASE / ORAL437 mgExact identifier — unii candidate
8 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
7 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1925d855-6d2f-4190-a96f-6dd1d4aaf4f6fbe8ddc3-1016-4826-98e8-cea34c752cc22021-09-09WarningsExact identifier
spl id: 1925d855-6d2f-4190-a96f-6dd1d4aaf4f6
spl set id: fbe8ddc3-1016-4826-98e8-cea34c752cc2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.