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

  • 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 August 21, 2019

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  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • muscular aches
      • headache
      • backache
      • the common cold
      • 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 inactives 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 of 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 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 25ºC (77ºF); 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

    ♥︎CVS
    Health™                            

    Compare to the active ingredient in Extra Strength Tylenol®*

    Caplets

     TAMPER EVIDENT: Use Only if This Blister is Intact

    NDC 59779-751-03

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

    Aspirin free    

    10 CAPLETS   Actual Size

    Travel Pack

    †This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol®.
    50844   REV0617A17503

    Distributed by:CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2017 CVS/pharmacy
    CVS.com®    1-800-SHOP-CVS
    V-13566

    CVS® Quality
    Money Back Guarantee

    CVS Health 44-175

    CVS Health 44-175

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-751
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;175
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-751-031 in 1 PACKAGE04/02/1993
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59779-751-962 in 1 PACKAGE04/02/1993
    210 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59779-751-291 in 1 CARTON04/02/199310/20/2015
    3150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34304/02/1993
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(59779-751)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(59779-751) , PACK(59779-751)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(59779-751)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(59779-751)
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