FDA.reportPublic FDA data

Bayer Aspirin

Manufacturer
Savings Distributors LLC
Effective date
2019-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:50

Label at a glance#

ProductBayer Aspirin
Active ingredientASPIRIN
Label structure8 sections

Indications and uses

temporarily relieves • headache • muscle pain • toothache • menstrual pain • pain and fever of colds • minor pain of arthritis

Dosage and administration

• drink a full glass of water with each dose • adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours • children under 12 years: consult a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves
• headache • muscle pain • toothache

• menstrual pain • pain and fever of colds • minor pain of arthritis

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 • 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

Do not use

OTC - DO NOT USE SECTION

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

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:
• 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
• fever lasts more than 3 days
• new symptoms occur
• ringing in the ears or a loss of hearing occurs

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• drink a full glass of water with each dose
• adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets

every 6 hours, not to exceed 12 tablets in 24 hours
• children under 12 years: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax*,corn starch, hypromellose, powdered cellulose, triacetin

*may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
212033aspirin 325 MG Oral TabletPSN1
211874BAYER Aspirin 325 MG Oral TabletPSN1
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBD1
212033aspirin 325 MG Oral TabletSCD1
212033ASA 325 MG Oral TabletSY1
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SY1
211874Bayer Aspirin 325 MG Oral TabletSY1

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
73097-003-022021-01-29C16284748780-1ba0f9c33-1d69-a910-e053-dadaa90a0b85Bayer Aspirin
73097-003-102021-01-29C16284748780-1ba0f9c33-1d69-a910-e053-dadaa90a0b85Bayer Aspirin
73097-003-502021-01-29C16284748780-1ba0f9c33-1d69-a910-e053-dadaa90a0b85Bayer Aspirin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73097-003-02Bayer Aspirin1 in 1 CARTONTABLET11
73097-003-02Bayer Aspirin2 in 1 POUCHTABLET21
73097-003-10Bayer Aspirin50 in 1 CARTONTABLET501
73097-003-10Bayer Aspirin2 in 1 POUCHTABLET21
73097-003-50Bayer Aspirin25 in 1 CARTONTABLET251
73097-003-50Bayer Aspirin2 in 1 POUCHTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73097-003BAYER ASPIRIN (ASPIRIN) TABLET [SAVINGS DISTRIBUTORS LLC]1Legacy NDC, 6 package rows20190711_8d59713e-78ea-1d00-e053-2995a90a4d67.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-2000-10EA - Each0280-20002c2a1512-6265-4d73-a1c1-d8eb5a2ef7b612014-09-03
0280-2000-20EA - Each0280-20006ca741a2-dc71-43d0-b14c-28aafb70dce512014-09-03
0280-2000-24EA - Each0280-20005dc5c258-ad1c-4cb0-8fa7-817b3389843712015-04-03
0280-2000-50EA - Each0280-2000035941cf-cae1-4bb3-a995-d7928643033312021-12-08

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73097-00373097-003-50, 73097-003-10, 73097-003-02
0280-2000

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POWDERED CELLULOSESMD1X3XO9MIACT
TRIACETINXHX3C3X673IACT
ASPIRINR16CO5Y76EACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bayer Genuine AspirinASPIRINBayer HealthCare LLC.44a08904-68b9-4d06-a28d-21aae3d6140c2025-12-04WarningsExact identifier
ndc (product): 0280-2000
8d596085-ec45-1cfe-e053-2995a90a16848d59713e-78ea-1d00-e053-2995a90a4d672019-07-10WarningsExact identifier
spl id: 8d596085-ec45-1cfe-e053-2995a90a1684
spl set id: 8d59713e-78ea-1d00-e053-2995a90a4d67

Reported adverse events (FAERS/openFDA)#

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