ST. JOSEPH LOW DOSE ASPIRIN- aspirin tablet, film coated

St. Joseph Low Dose Aspirin by

Drug Labeling and Warnings

St. Joseph Low Dose Aspirin by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Healthcare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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

  • SPL UNCLASSIFIED SECTION

    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

    PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box
  • INGREDIENTS AND APPEARANCE
    ST. JOSEPH LOW DOSE ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69536-181
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin81 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITE (PEACH) Scoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code SJ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 69536-181-151 in 1 BOX02/17/2017
    1150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC: 69536-181-361 in 1 BOX02/17/2017
    236 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC: 69536-181-121 in 1 BOX02/17/2017
    3120 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC: 69536-181-201 in 1 BOX02/17/2017
    4200 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC: 69536-181-541 in 1 BOX02/17/2017
    554 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC: 69536-181-651 in 1 BOX02/17/2017
    6365 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 (079675882)
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