Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet

  • NDC Code(s): 59779-519-05, 59779-519-08, 59779-519-12, 59779-519-15, view more
    59779-519-20, 59779-519-29, 59779-519-89
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 19, 2018

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

  • 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. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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 of 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 15º-30ºC (59º-86ºF)
    • 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

    CVS Health

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

    Rapid Release Gelcaps

    NDC 59779-519-20

    EXTRA STRENGTH
    Pain Relief
    ACETAMINOPHEN, 500 mg
    Pain reliever / Fever reducer
    Aspirin free

    225 GELCAPS

    RAPID
    RELEASE

    Actual Size

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

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels.    50844         ORG061551920

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2017 CVS/pharmacy   CVS.com® 
    1-800-SHOP CVS      V-11112

    √ CVS Quality
    Money Back Guarantee

    CVS Health 44-519

    CVS Health 44-519


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-519
    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 (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHELLAC (UNII: 46N107B71O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorRED, BLUEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-519-081 in 1 CARTON05/10/2004
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59779-519-121 in 1 CARTON05/10/2004
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:59779-519-151 in 1 CARTON05/10/2004
    350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:59779-519-201 in 1 CARTON05/10/2004
    4225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:59779-519-291 in 1 CARTON05/10/2004
    5150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:59779-519-05400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2004
    7NDC:59779-519-89225 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 - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(59779-519)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(59779-519)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(59779-519)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(59779-519)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(59779-519)