Label: ASPIRIN 325MG- aspirin tablet

  • NDC Code(s): 71800-041-01
  • Packager: Innovida Pharmaeutique Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 25, 2025

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

  • Active Ingredient

    Aspirin 325 mg(NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache 
    • menstrual pain 
    • a cold 
    • toothache 
    • muscle pain
    • minor pain of arthritis 
    • or as recommended by your doctor
  • 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

    • if you are allergic to aspirin or any other pain reliever/fever reducer 
    • if you have ever had an allergic reaction to this product or any of its ingredients

    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 high blood pressure, heart disease, liver cirrhosis, or kidney disease 
    • you have asthma you
    • are taking a prescription drug for diabetes, arthritis, or gout

    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: 
    • vomit blood 
    • feel faint
    • have bloody or black stools 
    • have stomach pain that does not get better 
    • ringing in the ears or a loss of hearing occurs 
    • new symptoms occur · pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days 
    • redness or swelling is present. 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 at 20 weeks or
    later in 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.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • do not take more than directed 
    • drink a full glass of water with each dose 
    • adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor · 
    • children under 12 years: do not use unless directed by a doctor
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 
    • see end flap for expiration date and lot number
  • Inactive Ingredients

    black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate,
    stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

  • SPL UNCLASSIFIED SECTION

    Questions or Comments? 1-888-462-4166

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 325MG 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71800-041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71800-041-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/10/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/10/2025
    Labeler - Innovida Pharmaeutique Corporation (080892908)