FDA.reportPublic FDA data

Aspirin

Manufacturer
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Effective date
2024-09-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:54:02

Label at a glance#

ProductAspirin Enteric 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 15-30ºC (59-86ºF)

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 have asthma
  • you are taking a diuretic 

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
    • have bloody or black stools
    • vomit blood
    • 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 occur

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 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, FD&C yellow #6, methacrylic acid copolymer, microcrystalline cellulose, pregelatinized starch (corn), silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, 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 Bayer® Low Dose Aspirin active ingredient†

Low Dose Safety Coated≠≠

Aspirin 81 mg

±aspirin regimen

Pain reliever (NSAID)

enteric coated 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.

Directed by: AmerisourceBergen

1 West First Avenue, Conshohocken, PA 19248

www.mygnp.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY Aspirin 81 mg
GOOD NEIGHBOR PHARMACY Aspirin 81 mg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-615-762020-11-04C16284748780-1ab0e2407-263f-f274-e053-dbdaa90a6471Drug Facts
46122-615-872020-11-04C16284748780-1ab0e2407-263f-f274-e053-dbdaa90a6471Drug Facts
46122-615-762020-09-27C16284748780-1ab0e2407-263f-f274-e053-dbdaa90a6471Drug Facts
46122-615-872020-09-27C16284748780-1ab0e2407-263f-f274-e053-dbdaa90a6471Drug Facts
46122-615-762020-09-25C16284748780-1ab0e2407-263f-f274-e053-dbdaa90a6471Drug Facts
46122-615-872020-09-25C16284748780-1ab0e2407-263f-f274-e053-dbdaa90a6471Drug Facts
46122-615-762020-07-22C16284748780-1ab0e2407-263f-f274-e053-dbdaa90a6471Drug Facts
46122-615-872020-07-22C16284748780-1ab0e2407-263f-f274-e053-dbdaa90a6471Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-615ASPIRIN ENTERIC SAFETY-COATED (ASPIRIN) TABLET [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]8Legacy NDC20240928_5d58312d-90aa-4efd-b10a-7a0cd02f1461.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-615-76EA - Each46122-615d8cf38fa-42d6-4f71-9bac-ae8930d1193f12021-01-08
46122-615-87EA - Each46122-615265fc4ca-35c9-40bb-92b9-9afd1ea440ce12020-07-13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-61546122-615-87, 46122-615-76

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TRIETHYL CITRATE8Z96QXD6UMIACT

Source Document#

Source XML · Source PDF

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
de9787bf-c120-4dc4-9fa0-0038e1e4ad155d58312d-90aa-4efd-b10a-7a0cd02f14612024-09-27WarningsExact identifier
spl id: de9787bf-c120-4dc4-9fa0-0038e1e4ad15
spl set id: 5d58312d-90aa-4efd-b10a-7a0cd02f1461

Reported adverse events (FAERS/openFDA)#

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