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St. Joseph Low Dose Aspirin

Dosage form: tablet, film coated
Ingredients: Aspirin 81mg
Labeler: Foundation Consumer Healthcare
NDC Code: 69536-181

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.

St. Joseph Low Dose Aspirin

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)


nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

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

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

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

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

Inactive ingredients

FD&C red #40, FD&C yellow #6, methacrylic acid copolymer, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, triethyl citrate

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

NDC 69536-181-36

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

ST. JOSEPH LOW DOSE ASPIRIN 
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-181
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin81 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
METHACRYLIC ACID 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SILICON DIOXIDE 
SODIUM BICARBONATE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TALC 
TRIETHYL CITRATE 
Product Characteristics
ColorWHITE (PEACH) Scoreno score
ShapeROUNDSize7mm
FlavorImprint CodeSJ
Contains    
Packaging
#Item CodePackage Description
1NDC:69536-181-151 BOTTLE in 1 BOX
1150 TABLET, FILM COATED in 1 BOTTLE
2NDC:69536-181-361 BOTTLE in 1 BOX
236 TABLET, FILM COATED in 1 BOTTLE
3NDC:69536-181-121 BOTTLE in 1 BOX
3120 TABLET, FILM COATED in 1 BOTTLE
4NDC:69536-181-201 BOTTLE in 1 BOX
4200 TABLET, FILM COATED in 1 BOTTLE
5NDC:69536-181-541 BOTTLE in 1 BOX
554 TABLET, FILM COATED in 1 BOTTLE
6NDC:69536-181-651 BOTTLE in 1 BOX
6365 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/30/2014
Labeler - Foundation Consumer Healthcare (079675882)

 
Foundation Consumer Healthcare

Medically reviewed on Jan 8, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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