Bayer

Manufacturer
Bayer HealthCare LLC. | Bayer HealthCare LLC Consumer Care
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:19:36

Label at a glance#

ProductBayer Low Dose
Active ingredientASPIRIN
Label structure10 sections

Indications and 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 Bayer Safety Coated 81 mg Aspirin

Dosage and administration

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: consult a doctor

Storage and handling

save carton for full directions and warnings store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 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. 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 Bayer Safety Coated 81 mg Aspirin

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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 are allergic to aspirin or any other pain reliever/fever reducer

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 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

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical right away.
  • 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
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs

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 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • save carton for full directions and warnings
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, brown iron oxide, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer type C, polysorbate 80, powdered cellulose, propylene glycol, shellac, sodium lauryl sulfate, triacetin, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-331-4536 (Mon - Fri 9AM - 5PM EST) or www.bayeraspirin.com

PRINCIPAL DISPLAY PANEL - 32 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

N 0280-2100-32

ASPIRIN REGIMEN



BAYER
®



ASPIRIN (NSAID) PAIN RELIEVER

LOW DOSE

81mg

Safety Coated



Aspirin

32 ENTERIC COATED TABLETS

Carton 200 countCarton 200 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN8
794229BAYER Aspirin 81 MG Delayed Release Oral TabletPSN8
794229aspirin 81 MG Delayed Release Oral Tablet [Bayer Aspirin]SBD8
308416aspirin 81 MG Delayed Release Oral TabletSCD8
308416ASA 81 MG Delayed Release Oral TabletSY8
794229ASA 81 MG Delayed Release Oral Tablet [Bayer Aspirin]SY8
308416aspirin 81 MG Enteric Coated Oral TabletSY8
794229Bayer Aspirin 81 MG Delayed Release Oral TabletSY8

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-2100-12BayerLow Dose120 in 1 BOTTLETABLET1208
0280-2100-12BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-20BayerLow Dose200 in 1 BOTTLETABLET2008
0280-2100-20BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-30BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-30BayerLow Dose300 in 1 BOTTLETABLET3008
0280-2100-32BayerLow Dose32 in 1 BOTTLETABLET328
0280-2100-32BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-40BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-40BayerLow Dose400 in 1 BOTTLETABLET4008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-2100-12EA - Each0280-2100db8bca36-42b3-4f34-b938-c46fa231cb9512013-02-13
0280-2100-20EA - Each0280-2100f15ca966-2c1e-4a44-b6fc-f2465fdc3d2f12013-02-13
0280-2100-30EA - Each0280-2100fdf42e42-2287-49a6-a9df-b78a699e448012017-06-15
0280-2100-32EA - Each0280-210012fe1c9b-2be1-44b8-b068-82f8acca90ad12013-02-13
0280-2100-40EA - Each0280-21007722e7b9-93c7-4b43-bdd4-0b53f635c16412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E2
ASPIRINACTIVE MOIETYR16CO5Y76E2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69332
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFO2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3572
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8J2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9M2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SHELLACINACTIVE INGREDIENT46N107B71O2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
TRIACETININACTIVE INGREDIENTXHX3C3X6732
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UM2

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
0280-21000280-2100-32, 0280-2100-12, 0280-2100-20, 0280-2100-30, 0280-2100-40

Ingredients#

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

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

Source Document#

Source XML

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 2 · 96 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET / ORAL52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOTABLET / ORAL0.79 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AMETHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JTABLET / ORAL489 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET / ORAL52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AMETHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JTABLET / ORAL489 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AMETHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JTABLET / ORAL489 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOTABLET / ORAL0.79 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOTABLET / ORAL0.79 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AMETHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JTABLET / ORAL489 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET / ORAL52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET / ORAL52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route+dosage form
6 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
Bayer Low DoseASPIRINBayer HealthCare LLC.075b103e-0bb4-4b7a-ac0e-5645bcbd0a072025-12-04WarningsExact identifier
ndc (package): 0280-2100-32
ndc (package): 0280-2100-30
ndc (package): 0280-2100-40
ndc (package): 0280-2100-12
ndc (package): 0280-2100-20
ndc (product): 0280-2100
ndc11 (package): 00280210012
ndc11 (package): 00280210040
ndc11 (package): 00280210032
ndc11 (package): 00280210030
ndc11 (package): 00280210020
spl id: 4526b594-84b4-b981-e063-6294a90a1aed
spl set id: 075b103e-0bb4-4b7a-ac0e-5645bcbd0a07

Reported adverse events (FAERS/openFDA)#

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