Label: ASPIRIN- aspirin tablet

  • NDC Code(s): 0603-0024-36
  • Packager: Qualitest Pharmaceutical, Inc.
  • 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 04/11

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

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Aspirin 81 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Pain reliever/fever reducer

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  • USES

    ■ temporarily relieves minor aches and pains due to the common cold, sore throat, headache, and toothache ■ temporarily reduces fever

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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. If allergy reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user ■ has had stomach ulcers or bleeding problems ■ takes a blood thinning (anticoagulant) or steroid drug ■ takes other drugs containing prescription or nonprescription NSAIDS (aspirin, ibuprofen, naproxen or others) ■ takes more or for a longer time than directed ■ is age 60 or older ■ has 3 or more alcoholic drinks everyday while using this product

    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

    Do not use

    ■ if you are allergic to aspirin or other pain relievers/fever reducers ■ for at least 7 days after tonsillectomy or oral surgery

    Ask a doctor before use if

    ■ stomach bleeding warning applies to user ■ user has history of stomach problems, such as heartburn ■ user has high blood pressure, heart disease, liver cirrhosis or kidney disease ■ user has asthma ■ user takes a diuretic ■ user has not been drinking fluids ■ user has lost a lot of fluids due to vomiting or diarrhea

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis

    Stop use and ask a doctor if

    ■ user experiences any of the following signs of stomach bleeding: feels faint, vomits blood, has bloody or black stools, has stomach pain that does not get better ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children) ■ fever gets worse or lasts for more than 3 days

    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 specifically 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

    ■ to be administered only under adult supervision ■ if possible use weight to dose, otherwise use age ■ repeat every 4 hours, while symptoms persist, up to a maximum of five doses in 24 hours or as directed by a doctor ■ drink a full glass of water with each does

    Age (yrs) Weight (lbs) Dosage
    under 3 under 32 consult a doctor
    3 to under 4 32 to 35 2 tablets
    4 to under 6 36 to 45 3 tablets
    6 to under 9 46 to 65 4 tablets
    9 to under 11 66 to 76 4 to 5 tablets
    11 to under 12 77 to 83 4 to 6 tablets
    Adults and children 12 years and over 5 to 8 tablets

    Other information

    store at room temperature

    You may report serious side effects to 1-888-952-0050

    Inactive ingredients

    Dextrates, FD&C yellow #6, flavor, saccharin sodium, starch

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  • DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0603-0024
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    FD&C YELLOW NO. 6  
    DEXTRATES  
    SACCHARIN SODIUM  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code AZ013
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-0024-36 36 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 11/03/2009
    Labeler - Qualitest Pharmaceutical, Inc. (011103059)
    Registrant - A&Z Pharmaceutical, Inc. (926820705)
    Establishment
    Name Address ID/FEI Business Operations
    A&Z Pharmaceutical, Inc. 926820705 manufacture
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