Label: ASPIRIN 325- aspirin tablet, coated

  • 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 August 5, 2020

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

  • Active ingredient (in each caplet)

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

  • Purpose

    Pain reliever

  • Uses

    for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

  • 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:

    • shock
    • hives
    • facial swelling
    • asthma (wheezing)

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • are age 60 or older
    • take more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product

    Do not use

    • 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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • 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:
    • 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
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • new symptoms occur

    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 (1-800-222-1222) right away.

  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 1 or 2 caplets every 4 hours not to exceed 12 caplets 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

    cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Walgreens

    Compare to Bayer® Regular
    Strength Aspirin 325 mg Safety
    Coated Caplets active ingredient††

    NDC 0363-0691-12

    Aspirin 325
    325 mg / PAIN RELIEVER (NSAID)

    REGULAR STRENGTH

    100 ENTERIC-COATED
    CAPLETS

    HEART
    HEALTH**

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

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Walgreens Pharmacist Recommended
    Walgreens Pharmacist Survey

    †† This product is not manufactured or
    distributed by Bayer HealthCare LLC,
    owner of the registered trademark
    Bayer® Regular Strength Aspirin 325 mg
    Safety Coated Caplets.

    50844           ORG031869112

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

    Walgreens
    100% SATISFACTION
    GUARANTEED

    walgreens.com ©2018 Walgreen Co.

    44-691

    44-691

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 325 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0691
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 691
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0691-121 in 1 CARTON07/01/2017
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34307/01/2017
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(0363-0691)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(0363-0691)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(0363-0691)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(0363-0691)