Label: ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN- aspirin tablet, chewable

  • NDC Code(s): 69536-281-10, 69536-281-36
  • Packager: Foundation Consumer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated November 5, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)1


    1
    nonsteroidal anti-inflammatory drug
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  • Purpose

    Pain reliever

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  • Uses

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

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  • Directions

    • 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
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  • Other information

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

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

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  • Questions or comments?

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

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Box

    NDC 69536-281-36

    • 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
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  • INGREDIENTS AND APPEARANCE
    ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69536-281
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 8mm
    Flavor ORANGE Imprint Code SJC
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69536-281-36 1 in 1 BOX 02/17/2017
    1 36 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:69536-281-10 3 in 1 BOX 02/17/2017
    2 108 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 02/17/2017
    Labeler - Foundation Consumer Healthcare LLC (079675882)
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