PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES, LLC]

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  • PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES, LLC]

PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES, LLC]
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NDC 36800-531-06
Set ID 02c25cdd-f4fd-414e-9e79-dd70488fbb96
Category HUMAN OTC DRUG LABEL
Packager Topco Associates, LLC
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each tablet)

    Acetaminophen 500 mg 

  • Purpose

    Pain reliever/fever reducer 

  • Uses

    • temporarily relieves minor aches and pains due to:
      • backache
      • muscular aches 
      • headache
      • the common cold
      • toothache
      • minor pain of arthritis
      • premenstrual and menstrual cramps
    • temporarily reduces fever 
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • blisters
    • rash
    • skin reddening

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have

    liver disease.

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition. 

    If pregnant or breast-feeding,

    ask a health professional before use. 

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

  • Directions

    • do not take more than directed
    • adults and children 12 years and over
      • take 2 tablets every 6 hours while symptoms last
      • do not take more than 6 tablets in 24 hours, unless directed by a doctor
      • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

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

    corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

  • Principal Display Panel

    TopCare®

    NDC 36800-531-06

    EXTRA STRENGTH
    Pain
    Reliever
    ACETAMINOPHEN
    PAIN RELIEVER / FEVER REDUCER

    • Easy to swallow
    • Contains no aspirin
    • Sweet coated 

    ACTUAL
    SIZE

    200 TABLETS - 500 mg EACH

    COMPARE TO
    EXTRA STRENGTH
    TYLENOL® 
    active ingredient*

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

    QUALITY GUARANTEED

    DISTRIBUTED BY TOPCO ASSOCIATES LLC,
    ELK GROVE VILLIAGE, IL 60007
    ©TOPCO LNK1216
    QUESTIONS? 1-888-423-0139
    topcare@topco.com
    www.topcarebrand.com


    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.

    50844   ORG081653106

    TopCare 44-531

    TopCare 44-531

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-531
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;531
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-531-06200 in 1 BOTTLE; Type 0: Not a Combination Product12/11/200502/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/11/200502/18/2022
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(36800-531)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(36800-531)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(36800-531)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(36800-531)
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