PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [DOLGENCORP, LLC]

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PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [DOLGENCORP, LLC]
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NDC 55910-812-08, 55910-812-32
Set ID ce9f4e0d-43fb-499a-b8a2-a997a14841c4
Category HUMAN OTC DRUG LABEL
Packager DOLGENCORP, LLC
Generic Name
Product Class
Product Number
Application Number PART343
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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
      • muscular aches
      • 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:

    • 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 (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 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
    • use by expiration date on package
  • 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

    Since 1903
    Rexall®

    EXTRA STRENGTH

    Pain Relief
    Acetaminophen 500 mg

    • Pain Reliever
    • Fever reducer
    • Contains no
    aspirin

    120
    Rapid Release
    Gelcaps

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

    50844       REV0417D51932

    Visit us at: Rexall.com or call 1-866-4-REXALL

    MANUFACTURED FOR DOLGENCORP, LLC
    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA
    Since 1903 Rexall® is a registered trademark of Rexall Sundown, Inc.

    Rexall 44-519

    Rexall 44-519

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-812
    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 YELLOW (UNII: EX438O2MRT)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    Colorred, blueScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-812-081 in 1 CARTON05/10/2004
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:55910-812-32120 in 1 BOTTLE; Type 0: Not a Combination Product05/10/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/10/2004
    Labeler - DOLGENCORP, LLC (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(55910-812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(55910-812) , pack(55910-812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(55910-812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(55910-812)
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