FDA.reportPublic FDA data

Aspirin

Manufacturer
St. Mary's Medical Park Pharmacy | St Mary's Medical Park Pharmacy
Effective date
2023-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:16:54

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

temporarily relieves: headache pain and fever of colds toothache menstrual pain muscle pain 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 unless directed by a doctor children under 12 years: do not use unless directed by a doctor

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) use by expiration date on package

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
    • pain and fever of colds
    • toothache
    • menstrual pain
    • muscle pain
    • 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:

  • shock
  • facial swelling
  • hives
  • 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 asthma
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • 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
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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 or 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 unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, polyethylene glycol, propylene glycol 

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aspasp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60760-854-242023-12-27C16284748780-1f386c649-f34f-0266-e053-dadaa90a7c1aRugby 44-157
60760-854-242023-01-30C16284748780-1f386c649-f34f-0266-e053-dadaa90a7c1aRugby 44-157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-854ASPIRIN TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]2Legacy NDC20231227_cb6bea9e-8614-0bb8-e053-2995a90a875c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-854-24EA - Each60760-85486f22e6c-e6e8-461d-a559-33bb9b705b7812021-11-09
0536-1054-05EA - Each0536-1054fc237185-1bbd-4a5e-bb81-7af422a69f9112021-06-02
0536-1054-29EA - Each0536-1054cadc1bc8-3468-44a1-9e73-8d4a6d8753e612015-04-03

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60760-85460760-854-24
0536-1054

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STARCH, CORNO8232NY3SJIACT
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
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
ndc (product): 0536-1054
50c1a76d-db4e-758d-e063-6294a90abdafcb6bea9e-8614-0bb8-e053-2995a90a875c2026-05-01WarningsExact identifier
spl set id: cb6bea9e-8614-0bb8-e053-2995a90a875c

Reported adverse events (FAERS/openFDA)#

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