Label: PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 0363-0175-03, 0363-0175-08, 0363-0175-12, 0363-0175-14, view more
    0363-0175-15, 0363-0175-20, 0363-0175-29, 0363-0175-37, 0363-0175-57, 0363-0175-99
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 3, 2024

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

View All Sections
  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • muscular aches
      • the common cold
      • backache
      • 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 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:

    • rash
    • skin reddening
    • blisters

    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

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

    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 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 caplets every 6 hours while symptoms last
      • do not take more than 6 caplets 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Walgreens

    Compare to the active ingredient in
    Tylenol® Extra Strength Caplets††

    NDC 0363-0175-03

    Pain Reliever
    ACETAMINOPHEN 500 mg
    PAIN RELIEVER/FEVER REDUCER

    Extra Strength

    10 CAPLETS

    ACTUAL SIZE

    OPEN HERE TO VIEW COMPLETE PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF PRINTED
    TEAR STRIP 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
    Kenvue Inc., owner of the registered trademark Tylenol® Extra Strength Caplets.

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

    50844

    REV0621A17503

    Walgreens 44-175

    Walgreens 44-175

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0175
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;175
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0175-0310 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/1993
    2NDC:0363-0175-081 in 1 CARTON04/02/199304/11/2024
    224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0363-0175-151 in 1 CARTON04/02/199303/16/2024
    350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:0363-0175-121 in 1 CARTON04/02/199312/09/2024
    4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:0363-0175-29150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/199307/21/2024
    6NDC:0363-0175-201 in 1 CARTON04/02/199302/07/2024
    6225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:0363-0175-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/199302/25/2024
    8NDC:0363-0175-991 in 1 CARTON04/02/199302/15/2022
    824 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    9NDC:0363-0175-371 in 1 CARTON04/02/199302/07/2021
    975 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    10NDC:0363-0175-571 in 1 CARTON04/02/199302/07/2021
    10125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/02/1993
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0363-0175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(0363-0175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0363-0175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(0363-0175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-0175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117597853pack(0363-0175)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!