Label: ASPIRIN- aspirin tablet, chewable

  • NDC Code(s): 57344-152-01, 57344-152-02
  • Packager: AAA Pharmaceutical, Inc.
  • 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 December 21, 2012

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 (NSAID1)


    1
    nonsteroidal anti-inflammatory drug
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  • Purpose

    Pain reliever

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  • Uses

    • temporarily relieves minor aches and pains
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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 have ever had an allergic reaction to 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
    • 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
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs

    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 (1-800-222-1222).

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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;
      do not exceed 48 tablets in 24 hours
    • children under 12 years: consult a doctor
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  • Other information

    • store between 20°-25°C (68°-77°F) in a dry place
    • retain carton for complete product information
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  • Inactive ingredients

    butylated hydroxytoluene, colloidal silicon dioxide, dextrates, FD&C yellow #6, flavor, mannitol, microcrystalline cellulose, modified corn starch, pregelatinized starch, saccharin sodium, starch, stearic acid, sucrose

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

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  • PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Carton

    RESTORE u

    NDC 57344-152-01

    COMPARE TO THE ACTIVE
    INGREDIENT IN ST JOSEPH®
    CHEWABLE ASPIRIN

    ADULT
    LOW DOSE

    Adult
    Chewable Aspirin

    Orange
    Flavored

    81mg

    Pain Reliever
    (NSAID)

    36 TABLETS - 81 mg each

    PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-152
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 9mm
    Flavor ORANGE Imprint Code TCL;334
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-152-01 1 in 1 CARTON
    1 36 in 1 BOTTLE, PLASTIC
    2 NDC:57344-152-02 3 in 1 CARTON
    2 36 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 12/15/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
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