ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN- aspirin tablet, chewable 
Foundation Consumer Healthcare LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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St. Joseph® Chewable Low Dose Aspirin

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)1


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

Warnings

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
  • asthma (wheezing)
  • shock

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

  • 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

  • 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 taking a prescription drug for gout, diabetes or arthritis

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.

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

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

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box

• 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
ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-281
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
DEXTRATES (UNII: G263MI44RU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code SJC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69536-281-361 in 1 BOX02/17/2017
136 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69536-281-103 in 1 BOX02/17/2017
2108 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/17/2017
Labeler - Foundation Consumer Healthcare LLC (079675882)

Revised: 12/2022
Document Id: a05b20f6-7b08-4d5f-96b9-5edf889aa8bc
Set id: 248cd302-e380-4837-bdae-9df620b67e8a
Version: 3
Effective Time: 20221207
 
Foundation Consumer Healthcare LLC