Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

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

View All Sections
  • Active ingredient (in each gelcap)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    • skin reddening
    • blisters
    • rash

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

    Do not use

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

    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
    • 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.

    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

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

  • Principal Display Panel

    Compare to Extra Strength Tylenol®
    Rapid Release Gels     active ingredient*

    NDC 68196-919-05

    Member's Mark®
    QUALITY GUARANTEED

    extra strength

    acetaminophen
    pain reliever/fever reducer
    gelcaps, 500 mg

    • non-aspirin
    • relieves minor aches & pains

    actual size

    400
    Gelcaps

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

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the registered
    trademark Extra Strength Tylenol® Rapid Release Gels.
    50844      REV0322B51905

    DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR 72716

    100% MONEY BACK GUARANTEE
    SUPERIOR QUALITY AND PERFORMANCE
    We would like to hear from you with any comments or suggestions.
    In the continental U.S. or Canada, you can call us at 1-800-426-9391
    from 8:30 a.m to 4:00 p.m. EST Monday-Friday.

    Members Mark 44-519

    Members Mark 44-519

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  EXTRA STRENGTH
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-919
    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:68196-919-05400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/10/2004
    Labeler - Sam's West Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464manufacture(68196-919) , pack(68196-919)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(68196-919)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(68196-919)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(68196-919)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(68196-919)
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!