St. Joseph Chewable Low Dose Aspirin

Manufacturer
Foundation Consumer Healthcare LLC
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:00

Label at a glance#

ProductSt. Joseph Chewable Low Dose Aspirin
Active ingredientASPIRIN
Label structure11 sections

Indications and uses

temporarily relieves minor aches and pains 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 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: 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 pains
  • 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

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 for 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 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: 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

corn starch, dextrates hydrated, FD&C yellow #6 aluminum lake, flavor, maltodextrin, sucralose

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
CHEWABLE PAIN RELIEVER (NSAID)

81 mg

AMERICA'S
ASPIRIN

100
YEARS

CHEWABLE

Orange
Flavored

36
Chewable
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
318272aspirin 81 MG Chewable TabletPSN4
211832St. Joseph Aspirin 81 MG Chewable TabletPSN4
211832aspirin 81 MG Chewable Tablet [St. Joseph Aspirin]SBD4
318272aspirin 81 MG Chewable TabletSCD4
318272ASA 81 MG Chewable TabletSY4
211832ASA 81 MG Chewable Tablet [St. Joseph Aspirin]SY4
211832St. Joseph Aspirin 81 MG Chewable 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
69536-281-10St. Joseph Chewable Low Dose Aspirin3 in 1 BOXTABLET, CHEWABLE34
69536-281-10St. Joseph Chewable Low Dose Aspirin108 in 1 BOTTLETABLET, CHEWABLE1084
69536-281-36St. Joseph Chewable Low Dose Aspirin1 in 1 BOXTABLET, CHEWABLE14
69536-281-36St. Joseph Chewable Low Dose Aspirin36 in 1 BOTTLETABLET, CHEWABLE364

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-281ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [FOUNDATION CONSUMER HEALTHCARE LLC]4Current NDC, Legacy NDC, 4 package rows20241204_248cd302-e380-4837-bdae-9df620b67e8a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-281-10EA - Each69536-281bbcc4b11-cc73-4495-af80-090cabd3cbec12018-07-03
69536-281-36EA - Each69536-281608d4e57-2f40-4617-b499-5924b9011ebf12018-07-03

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69536-28169536-281-36, 69536-281-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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 Chewable Low Dose AspirinASPIRINFoundation Consumer Healthcare LLC248cd302-e380-4837-bdae-9df620b67e8a2024-12-02WarningsExact identifier
ndc (package): 69536-281-10
ndc (package): 69536-281-36
ndc (product): 69536-281
ndc11 (package): 69536028110
ndc11 (package): 69536028136
spl id: 284c61e7-5ac2-6ca9-e063-6294a90a29bc
spl set id: 248cd302-e380-4837-bdae-9df620b67e8a

Reported adverse events (FAERS/openFDA)#

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