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

  • NDC Code(s): 50844-175-08, 50844-175-10, 50844-175-12, 50844-175-94
  • Packager: L.N.K. International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 12, 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
      • the common cold
      • toothache
      • backache
      • muscular aches
      • 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:

    • 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
    • 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 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

    QUALITY
    +PLUS

    NDC 50844-175-94

    *Compare to active ingredient in
    Extra Strength Tylenol® Caplets

    EXTRA STRENGTH
    PAIN RELIEVER
    Acetaminophen 500 mg
    PAIN RELIEVER/FEVER REDUCER

    ACTUAL
    SIZE

    100 Caplets

    CONTAINS NO ASPIRIN

    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® Caplets.

    50844     ORG061717512

    Distributed by
    LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788
    USA

    Quality Plus 44-175

    Quality Plus 44-175

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-175
    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:50844-175-94100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/1993
    2NDC:50844-175-081 in 1 CARTON04/02/199304/19/2022
    224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:50844-175-121 in 1 CARTON04/02/199304/19/2022
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:50844-175-101 in 1 CARTON04/02/199304/19/2022
    440 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 - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(50844-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(50844-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(50844-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(50844-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(50844-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117597853pack(50844-175)
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!