FDA.reportPublic FDA data

BAYER GENUINE ASPIRIN aspirin tablet

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:50:10

Label at a glance#

ProductBayer Genuine Aspirin
Active ingredientASPIRIN
Label structure13 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

Storage and handling

save carton for full directions and warnings store at room temperature

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg (NSAID)

1

1 1 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

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

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

Ask a doctor or pharmacist before use if you are

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 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

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carnauba wax 2 corn starch, hypromellose, powdered cellulose, triacetin

2

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1-800-331-4536

(Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GENUINE ASPIRIN

BAYER®

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

THE WONDER DRUG®

325mg

Safe Pain Relief Plus

Lifesaving Benefits

4 Coated Tablets

Bayer 4ctBayer 4ct

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GENUINE ASPIRIN

BAYER®

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

THE WONDER DRUG®

325mg

Safe Pain Relief Plus

Lifesaving Benefits

6 Coated Tablets

Bayer 6ctBayer 6ct

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GENUINE ASPIRIN

BAYER®

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

THE WONDER DRUG®

325mg

Safe Pain Relief Plus

Lifesaving Benefits

30 Pouches

2 COATED TABLETS EACH

Bayer 30ctBayer 30ct

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GENUINE ASPIRIN

BAYER®

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

THE WONDER DRUG®

325mg

Safe Pain Relief Plus

Lifesaving Benefits

25 POUCHES

2 COATED TABLETS EACH

Bayer 25ctBayer 25ct

Bayer CVP 4 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BAYER ® [Bayer cross]

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

GENUINE ASPIRIN

the wonder drug ®

SAFE PAIN RELIEF +

LIFESAVING BENEFITS

325

mg

[tablets image]

ACTUAL SIZE

Talk to your doctor or other

healthcare provider before using

this product for your heart.

4

Coated

Tablets

CVP

HEALTH

Bayer CVP 4 ctBayer CVP 4 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN10
212033aspirin 325 MG Oral TabletPSN10
198467aspirin 325 MG Delayed Release Oral TabletSCD10
212033aspirin 325 MG Oral TabletSCD10
198467ASA 325 MG Delayed Release Oral TabletSY10
212033ASA 325 MG Oral TabletSY10
198467aspirin 325 MG Enteric Coated Oral TabletSY10

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
29485-1017-4Bayer Genuine Aspirin2 in 1 POUCHTABLET, COATED210
29485-1017-4Bayer Genuine Aspirin2 in 1 BLISTER PACKTABLET, COATED210
29485-6526-4Bayer Genuine Aspirin2 in 1 POUCHTABLET, COATED210
29485-6526-4Bayer Genuine Aspirin2 in 1 CARTONTABLET, COATED210
29485-6924-6Bayer Genuine Aspirin3 in 1 BLISTER PACKTABLET, COATED310
29485-6924-6Bayer Genuine Aspirin2 in 1 POUCHTABLET, COATED210
29485-7533-2Bayer Genuine Aspirin25 in 1 BOXTABLET, COATED2510
29485-7533-2Bayer Genuine Aspirin2 in 1 POUCHTABLET, COATED210
29485-7533-3Bayer Genuine Aspirin2 in 1 POUCHTABLET, COATED210
29485-7533-3Bayer Genuine Aspirin30 in 1 BOXTABLET, COATED3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-1017BAYER GENUINE ASPIRIN TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]10Legacy NDC, 2 package rows20250101_d17834d7-cb3e-6bf2-e053-2a95a90ae5c1.zip
29485-6526BAYER GENUINE ASPIRIN TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]102 package rows20250101_d17834d7-cb3e-6bf2-e053-2a95a90ae5c1.zip
29485-6924BAYER GENUINE ASPIRIN TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]10Legacy NDC, 2 package rows20250101_d17834d7-cb3e-6bf2-e053-2a95a90ae5c1.zip
29485-7533BAYER GENUINE ASPIRIN TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, Legacy NDC, 4 package rows20250101_d17834d7-cb3e-6bf2-e053-2a95a90ae5c1.zip

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
29485-692429485-6924-6
29485-753329485-7533-2, 29485-7533-3
29485-101729485-1017-4
29485-652629485-6526-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIACETINXHX3C3X673IACT
POWDERED CELLULOSESMD1X3XO9MIACT
HYPROMELLOSES3NXW29V3WOIACT
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT
CARNAUBA WAXR12CBM0EIZIACT
TRIACETINXHX3C3X673IACT
POWDERED CELLULOSESMD1X3XO9MIACT
HYPROMELLOSES3NXW29V3WOIACT
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT
CARNAUBA WAXR12CBM0EIZIACT
CARNAUBA WAXR12CBM0EIZIACT
TRIACETINXHX3C3X673IACT
POWDERED CELLULOSESMD1X3XO9MIACT
HYPROMELLOSES3NXW29V3WOIACT
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT
TRIACETINXHX3C3X673IACT
POWDERED CELLULOSESMD1X3XO9MIACT
HYPROMELLOSES3NXW29V3WOIACT
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT
CARNAUBA WAXR12CBM0EIZIACT

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
Bayer Genuine AspirinBAYER GENUINE ASPIRINLil' Drug Store Products, Inc.d17834d7-cb3e-6bf2-e053-2a95a90ae5c12024-12-30WarningsExact identifier
ndc (package): 29485-6526-4
ndc (package): 29485-6924-6
ndc (package): 29485-7533-2
ndc (package): 29485-1017-4
ndc (package): 29485-7533-3
ndc (product): 29485-6924
ndc (product): 29485-6526
ndc (product): 29485-7533
ndc (product): 29485-1017
ndc11 (package): 29485652604
ndc11 (package): 29485692406
ndc11 (package): 29485101704
ndc11 (package): 29485753303
ndc11 (package): 29485753302
spl id: 2a82396b-4210-6196-e063-6394a90a72b1
spl set id: d17834d7-cb3e-6bf2-e053-2a95a90ae5c1

Reported adverse events (FAERS/openFDA)#

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