FDA.reportPublic FDA data

BAYER

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:43:20

Label at a glance#

ProductBAYER
Active ingredientASPIRIN
Label structure14 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg (NSAID) 1

1 nonsteroidal anti-inflammatory drug

Purposes

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

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 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

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. 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, powdered cellulose, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-331-4536

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

Bayer Aspirin Original, 4ct, Lil' Drug Store ® - PDP/Package

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.

6

Coated

Tablets

[ Lil' Drug Store ® logo]

PDP/PackagePDP/Package

Bayer Aspirin Original 4ct, TAVEL BASIX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Bayer cross]

BAYER ®

ASPIRIN (NSAID) PAIN RELEIEVER/FEVER REDUCER

GENUINE ASPIRIN

the wonder drug*

SAFE PAIN RELIEF +

LIFESAVING BENEFITS

[tablets image]

ACTUAL SIZE

325

mg

Talk to your doctoror other healthcare provider

before using this product for your heart.

4

Coated Tablets

[TRAVEL BASIX logo]

PDP/PackagePDP/Package

Bayer Aspirin Original 4ct, CVP ® HEALTH - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BAYER ®

[Bayer cross]

ASPIRIN (NSAID) PAIN RELEIEVER/FEVER REDUCER

GENUINE ASPIRIN

the wonder drug*

SAFE PAIN RELIEF +

LIFESAVING BENEFITS

[tablets image]

ACTUAL SIZE

325

mg

Talk to your doctoror other healthcare provider

before using this product for your heart.

4

Coated

Tablets

[CVP HEALTH logo]

PDP/PackagePDP/Package

Genuine Bayer ® Aspirin, 25pc Dispens-It Box, Lil' Drug Store ®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bayer ®

[Bayer Cross]

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

GENUINE ASPIRIN

the wonder drug ®

SAFE PAIN RELIEF +

LIFESAVING BENEFITS

[tablets image]

ACTUAL SIZE

Talk to your doctor or

other healthcare provider

before using this product

for your heart.

25 POUCHES

2 COATED TABLETS PER POUCH

[lIL' dRUG sTORE LOGO]

PDP/PackagePDP/Package

Genuine Bayer ® Aspirin, 30pc Dispens-It Box, Lil' Drug Store ®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BAYER ® [Bayer cross]

ASPIRIN (NSAID) PAIN RELEIEVER/FEVER REDUCER

GENUINE ASPIRIN

the wonder drug ®

SAFE PAIN RELIEF +

LIFESAVING BENEFITS

[tablets image]

ACTUAL SIZE

325

mg

Talk to your doctoror or

other healthcare provider

before using this product

for your heart.

30 POUCHES

2 COATED TABLETS PER POUCH

[Lil' Drug Store ® logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
212033aspirin 325 MG Oral TabletPSN8
211874BAYER Aspirin 325 MG Oral TabletPSN8
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBD8
212033aspirin 325 MG Oral TabletSCD8
212033ASA 325 MG Oral TabletSY8
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SY8
211874Bayer Aspirin 325 MG 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
66715-6426-2BAYER Aspirin Original, TRAVEL BASIX2 in 1 CARTONTABLET28
66715-6426-2BAYER Aspirin Original, TRAVEL BASIX2 in 1 POUCHTABLET28
66715-6526-2BAYER Aspirin Original, CVP HEALTH2 in 1 CARTONTABLET28
66715-6526-2BAYER Aspirin Original, CVP HEALTH2 in 1 POUCHTABLET28
66715-9726-2BAYER2 in 1 CARTONTABLET28
66715-9726-2BAYER2 in 1 POUCHTABLET28
66715-9726-3BAYER2 in 1 POUCHTABLET28
66715-9726-3BAYER3 in 1 CARTONTABLET38
66715-9726-7BAYER2 in 1 POUCHTABLET28
66715-9726-7BAYER25 in 1 BOX, UNIT-DOSETABLET258
66715-9726-8BAYER2 in 1 POUCHTABLET28
66715-9726-8BAYER30 in 1 BOX, UNIT-DOSETABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6426BAYER (ASPIRIN) TABLET BAYER ASPIRIN ORIGINAL, CVP HEALTH (ASPIRIN) TABLET BAYER ASPIRIN ORIGINAL, TRAVEL BASIX (ASPIRIN) TABLET [LIL' DRUG STORE PRODUCTS, INC.]8Current NDC, 2 package rows20241215_7f5d9ebe-8119-49a2-9380-eca18a5e5e85.zip
66715-6526BAYER (ASPIRIN) TABLET BAYER ASPIRIN ORIGINAL, CVP HEALTH (ASPIRIN) TABLET BAYER ASPIRIN ORIGINAL, TRAVEL BASIX (ASPIRIN) TABLET [LIL' DRUG STORE PRODUCTS, INC.]8Current NDC, 2 package rows20241215_7f5d9ebe-8119-49a2-9380-eca18a5e5e85.zip
66715-9726BAYER (ASPIRIN) TABLET BAYER ASPIRIN ORIGINAL, CVP HEALTH (ASPIRIN) TABLET BAYER ASPIRIN ORIGINAL, TRAVEL BASIX (ASPIRIN) TABLET [LIL' DRUG STORE PRODUCTS, INC.]8Current NDC, Legacy NDC, 8 package rows20241215_7f5d9ebe-8119-49a2-9380-eca18a5e5e85.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
ASPIRINACTIVE MOIETYR16CO5Y76E1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZ1
hypromellosesINACTIVE INGREDIENT3NXW29V3WO1
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9M1
starch, cornINACTIVE INGREDIENTO8232NY3SJ1
triacetinINACTIVE INGREDIENTXHX3C3X6731

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
66715-972666715-9726-2, 66715-9726-3, 66715-9726-7, 66715-9726-8
66715-652666715-6526-2
66715-642666715-6426-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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

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 1 · 45 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
powdered cellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
powdered cellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
powdered cellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
powdered cellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
powdered cellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
powdered cellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
powdered cellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
powdered cellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
powdered cellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form
9 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 Aspirin Original, TRAVEL BASIXASPIRINLil' Drug Store Products, Inc.7f5d9ebe-8119-49a2-9380-eca18a5e5e852024-11-27WarningsExact identifier
ndc (package): 66715-6426-2
ndc (package): 66715-6526-2
ndc (package): 66715-9726-3
ndc (package): 66715-9726-7
ndc (package): 66715-9726-2
ndc (package): 66715-9726-8
ndc (product): 66715-6526
ndc (product): 66715-9726
ndc (product): 66715-6426
ndc11 (package): 66715972608
ndc11 (package): 66715972607
ndc11 (package): 66715642602
ndc11 (package): 66715972602
ndc11 (package): 66715972603
ndc11 (package): 66715652602
spl id: 27e5d448-9afb-9188-e063-6394a90a5fff
spl set id: 7f5d9ebe-8119-49a2-9380-eca18a5e5e85

Reported adverse events (FAERS/openFDA)#

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