Label: PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet, coated

  • NDC Code(s): 0363-0519-08, 0363-0519-12, 0363-0519-15, 0363-0519-19, view more
    0363-0519-20, 0363-0519-29, 0363-0519-54, 0363-0519-92
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 17, 2023

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  • Active ingredient (in each gelcap)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • the common cold
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • 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 of acetaminophen in 24 hours
    • 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

    • 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.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center 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 gelcaps every 6 hours while symptoms last
      • do not take more than 6 gelcaps 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 15°-30°C (59°-86°F)
    • avoid high humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Walgreens

    Compare to the active ingredient in Extra
    Strength Tylenol® Rapid Release Gels††

    NDC 0363-0519-92

    Pain
    Reliever
    ACETAMINOPHEN     500 mg /
    PAIN RELIEVER / FEVER REDUCER

    Extra Strength

    150 GELCAPS

    ACTUAL SIZE

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

    Walgreens Pharmacist Recommended.
    Our pharmacists recommend the
    Walgreens brand. We invite you to
    compare to national brands.
    ††This product is not manufactured or
    distributed by Johnson & Johnson
    Corporation, owner of the registered
    trademark Extra Strength Tylenol® Rapid
    Release Gels.

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com     ©2021 Walgreen Co.

    50844    ORG032251929

    Walgreens 44-519

    Walgreens 44-519

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0519
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred, blueScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0519-081 in 1 CARTON05/10/2004
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-0519-151 in 1 CARTON05/10/2004
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0363-0519-121 in 1 CARTON05/10/2004
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:0363-0519-92150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2004
    5NDC:0363-0519-191 in 1 CARTON05/10/200410/05/2018
    58 in 1 VIAL; Type 0: Not a Combination Product
    6NDC:0363-0519-201 in 1 CARTON05/10/200404/13/2024
    6225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:0363-0519-29150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/200407/07/2024
    8NDC:0363-0519-54375 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/200405/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/10/2004
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464manufacture(0363-0519) , pack(0363-0519)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(0363-0519)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0363-0519)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(0363-0519)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-0519)
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