FDA.reportPublic FDA data

Aspirin 81

Manufacturer
WALGREENS | TIME CAP LABORATORIES, INC.
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:51

Label at a glance#

ProductAspirin 81
Active ingredientASPIRIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose
Pain reliever


INDICATIONS & USAGE SECTION

Uses

• temporarily relieves minor aches and pains

• ask your doctor about other uses for enteric coated 81 mg Aspirin.

WARNINGS SECTION

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 • asthma (wheezing) • shock

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

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer.

OTC - ASK DOCTOR SECTION

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 are taking a diuretic
  • you have asthma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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
  • an allergic reaction occurs

Seek medical help right away if

  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

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 unless directed by a doctor

OTHER SAFETY INFORMATION

Other information

  • Store at 20-25°C (68-77°F)
  • close cap tightly after use

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, triethyl citrate

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

482R_WALG_500ct482R_WALG_500ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN3
308416aspirin 81 MG Delayed Release Oral TabletSCD3
308416ASA 81 MG Delayed Release Oral TabletSY3
308416aspirin 81 MG Enteric Coated Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-6452-502025-02-10C16284748780-12cef2736-8f73-d83d-e063-dadaa90ab31f482R Walgreens 0363-6452 Aspirin 81 mg 500s
0363-6452-502025-01-30C16284748780-12cef2736-8f73-d83d-e063-dadaa90ab31f482R Walgreens 0363-6452 Aspirin 81 mg 500s

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6452-50Aspirin 81500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6452ASPIRIN 81 (ASPIRIN) TABLET [WALGREENS]3Current NDC, Legacy NDC, 1 package rows20250212_d71a571e-e2ce-7e0a-e053-2a95a90a53e0.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-64520363-6452-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
STARCH, CORNO8232NY3SJIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POLYSORBATE 806OZP39ZG8HIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERNX76LV5T8JIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

Source Document#

Source XML

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
Aspirin 81ASPIRINWALGREENSd71a571e-e2ce-7e0a-e053-2a95a90a53e02025-01-30WarningsExact identifier
ndc (package): 0363-6452-50
ndc (product): 0363-6452
ndc11 (package): 00363645250
spl id: 2ceb69d1-a3f4-c3da-e063-6394a90ae9a7
spl set id: d71a571e-e2ce-7e0a-e053-2a95a90a53e0

Reported adverse events (FAERS/openFDA)#

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