Label: ASPIRIN tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 24, 2019

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

  • ACTIVE INGREDIENT

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

  • PURPOSE

    Pain Reliever/Fever Reducer

  • 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

  • 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)
    • have 3 or more alcholic drinks every day while using this product

  • DO NOT USE

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

  • 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
  • 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
  • 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
    • ringing in the ears or loss of hearing occurs
    • 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

  • 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

  • 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

  • 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

  • INACTIVE INGREDIENT

    Inactive Ingredients: Microcrystalline Cellulose, Povidone K-30, Starch 1500

  • PRINCIPAL DISPLAY PANEL

    5521Aspirinv19f.jpg5521Aspirinv19f.jpg5521Aspirinv19f.jpg5521Aspirinv19f.jpg

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code TCL011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0102-450 in 1 BOX, UNIT-DOSE06/04/1986
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0102-7125 in 1 BOX, UNIT-DOSE06/04/1986
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0102-8250 in 1 BOX, UNIT-DOSE06/04/1986
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:50332-0102-325 in 1 BOX, UNIT-DOSE06/04/1986
    42 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34306/04/1986
    Labeler - HART Health (069560969)