FDA.reportPublic FDA data

St. Joseph Low Dose Aspirin

Manufacturer
Foundation Consumer Healthcare
Effective date
2024-04-26
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:11:37

Label at a glance#

ProductSt. Joseph Low Dose Aspirin
Active ingredientASPIRIN
Label structure11 sections

Indications and uses

temporarily relieves minor aches and pain ask your doctor about other uses for St. Joseph Safety Coated 81 mg Aspirin

Dosage and administration

drink a full glass of water with each dose adults and children 12 years of age 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 of age: do not use unless directed by a doctor

Storage and handling

store at 20-25°C (68-77°F) close cap tightly after use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID) 1

1 nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pain
  • ask your doctor about other uses for St. Joseph Safety Coated 81 mg Aspirin

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 useif 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 aretaking a prescription drug for gout, diabetes or 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
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • new symptoms occur. These could be signs of a serious condition.

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 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 of age 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 of age: do not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • close cap tightly after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal anhydrous silica, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid- ethyl acrylate copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-785-6381weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

Dist. by: Foundation Consumer Healthcare, LLC.
Pittsburgh, PA 15205

PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

•ADULT ASPIRIN REGIMEN †•

ST. JOSEPH ®

LOW DOSE ASPIRIN
SAFETY COATED
PAIN RELIEVER (NSAID)

81mg

AMERICA'S
ASPIRIN

100
YEARS

DOCTOR RECOMMENDED

Enteric
Coated

36
Coated
Tablets

PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box
PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN7
749795St. Joseph Aspirin 81 MG Delayed Release Oral TabletPSN7
749795aspirin 81 MG Delayed Release Oral Tablet [St. Joseph Aspirin]SBD7
308416aspirin 81 MG Delayed Release Oral TabletSCD7
308416ASA 81 MG Delayed Release Oral TabletSY7
749795ASA 81 MG Delayed Release Oral Tablet [St. Joseph Aspirin]SY7
308416aspirin 81 MG Enteric Coated Oral TabletSY7
749795St. Joseph Aspirin 81 MG Delayed Release Oral TabletSY7

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
69536-181-12St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-12St. Joseph Low Dose Aspirin120 in 1 BOTTLETABLET, FILM COATED1207
69536-181-15St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-15St. Joseph Low Dose Aspirin150 in 1 BOTTLETABLET, FILM COATED1507
69536-181-20St. Joseph Low Dose Aspirin200 in 1 BOTTLETABLET, FILM COATED2007
69536-181-20St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-36St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-36St. Joseph Low Dose Aspirin36 in 1 BOTTLETABLET, FILM COATED367
69536-181-54St. Joseph Low Dose Aspirin54 in 1 BOTTLETABLET, FILM COATED547
69536-181-54St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-65St. Joseph Low Dose Aspirin365 in 1 BOTTLETABLET, FILM COATED3657
69536-181-65St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-181ST. JOSEPH LOW DOSE ASPIRIN (ASPIRIN) TABLET, FILM COATED [FOUNDATION CONSUMER HEALTHCARE]7Current NDC, Legacy NDC, 12 package rows20240430_dbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-181-12EA - Each69536-1811d7ff21d-4f1d-4119-9c58-b027d2cdbce912018-07-03
69536-181-20EA - Each69536-18106a01f51-f94d-4687-b440-e7ba86d6cf9a12018-07-03
69536-181-36EA - Each69536-18116b344f7-9fbd-47df-b07c-dc895fd931ee12018-07-03
69536-181-65EA - Each69536-181a3795353-1057-46eb-9524-57c51e491f1712018-07-03

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69536-18169536-181-15, 69536-181-36, 69536-181-12, 69536-181-20, 69536-181-54, 69536-181-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
METHACRYLIC ACID1CS02G8656IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
ASPIRINR16CO5Y76EACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TRIACETINXHX3C3X673IACT
POLYDEXTROSEVH2XOU12IEIACT
SHELLAC46N107B71OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT

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
St. Joseph Low Dose AspirinASPIRINFoundation Consumer Healthcaredbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f2024-04-26WarningsExact identifier
ndc (package): 69536-181-15
ndc (package): 69536-181-54
ndc (package): 69536-181-65
ndc (package): 69536-181-20
ndc (package): 69536-181-36
ndc (package): 69536-181-12
ndc (product): 69536-181
ndc11 (package): 69536018154
ndc11 (package): 69536018112
ndc11 (package): 69536018136
ndc11 (package): 69536018120
ndc11 (package): 69536018115
ndc11 (package): 69536018165
spl id: 1705ba3b-36e3-df62-e063-6394a90ab583
spl set id: dbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f

Reported adverse events (FAERS/openFDA)#

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