Label: ASPIRIN tablet, film coated

  • NDC Code(s): 36800-157-12, 36800-157-14, 36800-157-17, 36800-157-87
  • Packager: Topco Associates, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 7, 2023

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  • Active ingredient (in each tablet)

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

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves:

    • pain and fever of colds
    • toothache
    • menstrual pain
    • muscle pain
    • headache
    • minor pain of arthritis
  • 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
    • shock
    • 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 a blood thinning (anticoagulant) or steroid drug
    • have had stomach ulcers or bleeding problems
    • take more or for a longer time than directed
    • 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
    • are age 60 or older

    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 asthma
    • 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

    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
    • ringing in the ears or a loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • new symptoms occur
    • 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.

  • 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 or 2 tablets every 4 hours or 3 tablets every 6 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

    • use by expiration date on package
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    corn starch, hypromellose, polyethylene glycol, propylene glycol

  • Questions or comments?

    1-888-423-0139

  • Principal display panel

    TopCare®
    health

    NDC 36800-157-14

    COMPARE TO GENUINE BAYER® ASPIRIN
    ACTIVE INGREDIENT†

    REGULAR STRENGTH
    Aspirin
    325 mg
    PAIN RELIEVER •  FEVER REDUCER
    (NSAID)

    • Safe Pain Relief
    • Sodium &
    Caffeine Free

    500 COATED TABLETS

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

    †This product is not manufactured or distributed by Bayer AG,
    owner of the registered trademark Genuine Bayer® Aspirin.

    50844 REV0122C15714

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007
    ©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139
    topcare@topco.com www.topcarebrand.com

    Visit here for more information: http://topbrnds.com/48ZZSP

    TopCare 44-157

    TopCare 44-157

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-157
    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 44;157;ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-157-12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/10/1996
    2NDC:36800-157-871 in 1 CARTON02/10/1996
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:36800-157-17300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/10/1996
    4NDC:36800-157-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/10/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/10/1996
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(36800-157)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(36800-157)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(36800-157)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(36800-157)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(36800-157)
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