FDA.reportPublic FDA data

Aspirin

Manufacturer
Care One (Retail Business Services, LLC.)
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:09:23

Label at a glance#

ProductAspirin Low Dose Safety Coated
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 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

store between 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

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 safety coated 81 mg aspirin

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
  • shock
  • asthma (wheezing)

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
  • if you have ever had an allergic reaction to this product or any of its ingredients

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

These could be signs of a serious condition.

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 (1-800-222-1222) 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

  • store between 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

 croscarmellose sodium, D&C yellow #10, lactose monohydrate, methacrylic acid, microcrystalline cellulose 102, polacrilin potassium,  propylene glycol 6000, polyvinyl alcohol, purified talc, silicon dioxide,  sodium lauryl sulfate, soybean, titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient in Bayer® Low Dose Aspirin†

low dose

ASPIRIN 81 mg

Pain Reliever (NSAID)

Enteric Safety Coated≠≠

Aspirin regimen≠

TABLETS

†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.

‡Talk to your doctor or other healthcare provider before using this product for your heart. Aspirin is not right for everyone.

≠≠Coating helps protect against stomach upset

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC,

SALISBURY, NC 28147

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE Low Dose Aspirin 81 mg
CAREONE Low Dose Aspirin 81 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN4
308416aspirin 81 MG Delayed Release Oral TabletSCD4
308416ASA 81 MG Delayed Release Oral TabletSY4
308416aspirin 81 MG Enteric Coated Oral TabletSY4

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
72476-263-12AspirinLow Dose Safety Coated1 in 1 BOXTABLET, COATED14
72476-263-12AspirinLow Dose Safety Coated120 in 1 BOTTLE, PLASTICTABLET, COATED1204
72476-263-30AspirinLow Dose Safety Coated300 in 1 BOTTLE, PLASTICTABLET, COATED3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-263ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]4Current NDC, Legacy NDC, 3 package rows20240306_6659e103-fa03-4de0-af42-d2fbd548a87c.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-26372476-263-12, 72476-263-30

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
ASPIRINR16CO5Y76EACTIB
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLACRILIN POTASSIUM0BZ5A00FQUIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
SOYBEANL7HT8F1ZODIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 Low Dose Safety CoatedASPIRINCare One (Retail Business Services, LLC.)6659e103-fa03-4de0-af42-d2fbd548a87c2024-03-05WarningsExact identifier
ndc (package): 72476-263-30
ndc (package): 72476-263-12
ndc (product): 72476-263
ndc11 (package): 72476026330
ndc11 (package): 72476026312
spl id: c1884ada-373c-47d9-8b7f-63b9d9067ac1
spl set id: 6659e103-fa03-4de0-af42-d2fbd548a87c

Reported adverse events (FAERS/openFDA)#

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