Label: ASPIRIN- aspirin tablet

  • NDC Code(s): 50332-0102-1, 50332-0102-4, 50332-0102-7, 50332-0102-8
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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  • ACTIVE INGREDIENT

    Aspirin (NSAID)* 325mg (*non-steroidal anti-inflammatory drug)

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  • INDICATIONS & USAGE

    Uses:

    Temporarily relieves minor aches and pains due to:

    • headache
    • backache
    • muscular aches
    • minor arthritis pain
    • common cold
    • toothache
    • menstrual cramps

    Temporarily reduces fever

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  • WARNINGS

    Warnings:

    Reye's Syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin

    Allergy altert: Aspirin may cause a several 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 ulers or bleeding problems
    • take more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, others)

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  • DO NOT USE

    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

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  • ASK DOCTOR

    Ask a doctor before use if:

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you:

    • take any other drug containing an NSAID
    • take a blood thinning (anticoagulant) or steroid drug
    • take any drug for diabetes, gout, or arthritis
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  • STOP USE

    Stop use and ask a doctor if:

    • an allergic reaction occurs, seek medical help right away
    • fever gets worse or lasts more than 3 days
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present in the painful area
    • new symptoms occur
    • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

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  • PREGNANCY OR BREAST FEEDING

    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

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  • KEEP OUT OF REACH OF CHILDREN

    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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  • DOSAGE & ADMINISTRATION

    Directions: Do not take more than directed.

    Adults and children 12 years of age and over:

    • take 1 or 2 tablets with water every 4 hours while symptoms persist
    • do not take more than 12 tablets in 24 hours unless directed by a doctor

    Children under 12 years of age: ask a doctor

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Corn Starch, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0102
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code TCL011
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0102-4 50 in 1 BOX, UNIT-DOSE
    1 2 in 1 PACKET
    2 NDC:50332-0102-7 125 in 1 BOX, UNIT-DOSE
    2 2 in 1 PACKET
    3 NDC:50332-0102-8 250 in 1 BOX, UNIT-DOSE
    3 2 in 1 PACKET
    4 NDC:50332-0102-1 500 in 1 BOX, UNIT-DOSE
    4 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 06/04/1986
    Labeler - HART Health (069560969)
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