Label: ASPIRIN tablet

  • NDC Code(s): 50332-0139-3, 50332-0139-4, 50332-0139-7, 50332-0139-8
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

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

  • 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

    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 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 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

    • 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: corn starch, hypromellose,  polyethylene glycol, propylene glycol

  • PRINCIPAL DISPLAY PANEL

    5521Aspirinv23f.jpg5521Aspirinv23f.jpg

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0139
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code ASPIRIN;44;157
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0139-450 in 1 BOX, UNIT-DOSE01/01/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0139-7125 in 1 BOX, UNIT-DOSE01/01/2023
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0139-8250 in 1 BOX, UNIT-DOSE01/01/2023
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:50332-0139-325 in 1 BOX, UNIT-DOSE01/01/2023
    42 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01/01/2023
    Labeler - HART Health (069560969)