Label: ASPIRIN tablet, chewable

  • 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 June 13, 2019

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    for the temporary relief of minor aches and pains

  • 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
    for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

    Ask a doctor before use if

    you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    stomach bleeding warning applies to you
    you have a history of stomach problems, such as heartburn
    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
    fever gets worse or lasts for more than 3 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).

  • 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: consult a doctor
  • Other information

    store at 20-25°C (68-77°F)
  • Inactive ingredients

    corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium

  • Questions or comments?

    1-800-616-2471

  • Principal Display Panel

    COMPARE TO the active ingredient of BAYER® CHEWABLE ASPIRIN

    Aspirin 81 mg Pain Reliever (NSAID)

    Chewable Orange Flavor

    Aspirin Regimen

    Low Dose

    Actual Size

    Talk to your doctor or other healthcare provider before using this product for your heart.

    36 Tablets

    467-5c-aspirin.jpg
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-4040
    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 YELLOW NO. 6 (UNII: H77VEI93A8)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize8mm
    FlavorORANGEImprint Code L467
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-4040-731 in 1 CARTON12/12/2007
    136 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/12/2007
    Labeler - Major Pharmaceuticals (191427277)